Medicament preparation and treatment devices, methods, and systems

ABSTRACT

A medicament preparation system, according to an embodiment, includes a water purification module and a medicament proportioning module. The system is configured to allow convenient and safe use in a home environment or a critical care environment as well as others affording safety, reliability, and a compact form factor.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a U.S. national stage filing under 35 U.S.C. § 371of International Application No. PCT/US2015/052385 filed Sep. 25, 2015,which claims the benefit of U.S. Provisional Application No. 62/055,022,filed Sep. 25, 2014, both of which are hereby incorporated by referencein their entireties.

FIELD

The presently disclosed subject matter relates generally to medicaltreatment. In details of embodiments, the disclosed subject matterrelate to medical fluid preparation and utilization in the performanceof medical treatments.

BACKGROUND

There are many types of blood processing and fluid exchange procedures,each providing different therapeutic effects and demanding differentprocessing criteria. Some procedures entail the removal of blood oranother fluid from an individual and the return of blood or anotherfluid to the individual in a controlled fashion. Other types use naturalbody tissues to exchange blood components with a medicament. Examples ofsuch procedures include hemofiltration (HF), hemodialysis (HD),hemodiafiltration (HDF), and peritoneal dialysis (PD). A commonrequirement of such procedures is the provision of large quantities ofmedicament such as dialysate that has a precise mixture of solutecomponents and is free of contaminants and pyrogenic materials.

Known systems for preparing medicaments such as dialysate are continuousproportioning systems and batch mixing systems. Carrying out treatmentprocedures using medicaments may employ special-purpose machinery. Inthe dialysis treatments listed above, devices called cyclers are oftenused. These pump fluid and may also pump blood, depending on thetreatment. In the process of pumping, they precisely proportion the netamounts of fluid supplied and discharged and ensure safety by variousmeans including monitoring of pressure, temperature, leaks, and othertreatment conditions. In principle, these treatments are relativelysimple, but because of the need for patient safety and health outcomes,treatment procedures and treatment systems are complex.

Home delivery of these treatments raises concerns about safety andtreatment efficacy. One of the drawbacks of home treatment is the needfor a supply of purified water. In clinics, large reverse osmosis plantsprovide a continuous supply of purified water. In the home, such largesystems may not be practical because they require high volume of waterand drainage. Installing and using relevant components can be adifficult and expensive task and may require modifications to apatient's home. In addition, the systems for the production of properlymixed medicaments in pure form require a high level of precision andsafeguards as well as training and maintenance. To provide effective andsafe systems for home delivery of blood treatments, there is an on-goingneed for innovations in these areas and others.

SUMMARY

A medicament preparation system, according to an embodiment, includes awater purification module and a medicament proportioning module. Thesystem is configured to allow convenient and safe use in a homeenvironment or a critical care environment as well as others affordingsafety, reliability, and a compact form factor.

Objects and advantages of embodiments of the disclosed subject matterwill become apparent from the following description when considered inconjunction with the accompanying drawings.

BRIEF DESCRIPTION OF DRAWINGS

Embodiments will hereinafter be described in detail below with referenceto the accompanying drawings, wherein like reference-numerals representlike elements. The accompanying drawings have not necessarily been drawnto scale. Where applicable, some features may not be illustrated toassist in the description of underlying features.

FIG. 1 shows an overview of an online system that includes a waterpurification module, proportioning medicament proportioning module, anda cycler forming an online treatment system, according to embodiments ofthe disclosed subject matter.

FIG. 2 shows details of the water purification module of the embodimentof FIG. 1, according to embodiments of the disclosure subject matter.

FIGS. 3A and 3B illustrate an optional mechanism that may be providedwith the water purification module 102, the medicament proportioningmodule 104, or any other similar mechanism that receives replaceabletagged components (i.e., ones having data carriers), according toembodiments of the disclosure subject matter.

FIG. 4 shows a variant of the water purification module of theembodiment of FIG. 2 in which respective data carrier readers 251, 252,254, 255, 256, and 257 are provided, according to embodiments of thedisclosure subject matter.

FIG. 5 shows a flow chart representing a method for permitting orrefusing the use of a replaceable tagged component in a device utilizingthe same, according to embodiments of the disclosure subject matter.

FIGS. 6A through 6C illustrate features related to installation ofreplaceable tagged components in a module that consumes them andcommunication by data carriers with a controller of the module,according to embodiments of the disclosed subject matter.

FIG. 7 shows an overview of an online water purification, proportioningmedicament generation, and treatment system, according to embodiments ofthe disclosed subject matter.

FIG. 8A shows details of an embodiment of medicament proportioningmodule, according to embodiments of the disclosed subject matter.

FIG. 8B shows details of an embodiment of medicament proportioningmodule, according to other embodiments of the disclosed subject matter.

FIGS. 8C through 8H and FIG. 8J show mechanisms for interfacing the flowof fluid between a water purification module and a medicamentproportioning module, according to embodiments of the disclosed subjectmatter.

FIG. 9A shows a disposable including a fluid circuit cartridge andconcentrate containers according to embodiments of the disclosed subjectmatter.

FIG. 9B shows a disposable including a fluid circuit cartridge andconcentrate containers as well as a dry solute container according toembodiments of the disclosed subject matter.

FIG. 9C shows a disposable including a fluid circuit cartridge andconcentrate containers, one of the concentrate containers beingconnected to dilute saturate an inline applied flow of water to generatea concentrate, according to embodiments of the disclosed subject matter.

FIG. 10 shows further details of a fluid circuit cartridge according toembodiments of the disclosed subject matter.

FIGS. 11A through 11D show features of a conductivity and temperaturemeasurement cell that, according to embodiments, can be integrated inthe fluid circuit cartridge of FIG. 9C and others disclosed herein,according to embodiments of the disclosed subject matter.

FIGS. 12A and 12B show a pressure regulating component that, accordingto embodiments, can be employed with the fluid circuit cartridge of FIG.9C and others disclosed herein, according to embodiments of thedisclosed subject matter.

FIG. 12C shows the embodiment of FIGS. 12A and 12B with a fluid circuitcartridge according to embodiments of the disclosed subject matter.

FIGS. 13A and 13B show front (FIG. 13A) and back (FIG. 13B) sides of amedicament preparation system, according to embodiments of the disclosedsubject matter.

FIGS. 13C, 13D, and 13E illustrate a medicament preparation system andconnecting scheme, according to further embodiments of the disclosedsubject matter.

FIGS. 14A through 14D illustrate disposable filter cartridge connectionand other mechanical features of a medicament preparation system,according to embodiments of the disclosed subject matter.

FIGS. 15A and 15B illustrate disposable fluid circuits and featuresinvolved in their assembly, according to embodiments of the disclosedsubject matter.

FIGS. 16A and 16B are flow charts showing methods of making the fluidcircuits of FIGS. 15A and 15B, respectively, and others, according toembodiments of the disclosed subject matter.

FIG. 17 shows an arrangement of elements that show how electrical,thermal, and mechanical engagement (contact) with sensor instrumentationand actuated elements can be made according to embodiments of thedisclosed subject matter.

FIGS. 18A and 18B show details of fluid circuit cartridges according toembodiments of the disclosed subject matter.

FIG. 19 shows schematically and figuratively a combined waterpurification, medicament proportioning and treatment system to highlighta feature by which leakage current is minimized, according toembodiments of the disclosed subject matter.

FIGS. 20A through 20D illustrate embodiments of fluid proportioningsystems that illustrate features of the disclosed embodiment, accordingto embodiments of the disclosed subject matter.

FIG. 21 shows an air break according to embodiments of the disclosedsubject matter.

FIG. 22 shows a treatment system with an air break for purposes ofdiscussing its function in a medicament preparation system or atreatment system, according to embodiments of the disclosed subjectmatter.

FIGS. 23A and 23B show embodiments of a conductivity measurementcomponent that may be used with any cartridge embodiments, orsubstituted with equivalent conductivity measurement components thereofin any of the embodiments disclosed or claimed.

DETAILED DESCRIPTION

FIG. 1 shows an overview of an online water purification, proportioningmedicament generation, and treatment system 100, according toembodiments of the disclosed subject matter. A water purification module102 receives tap water 108 from a municipal water supply. The waterpurification module 102 purifies the water and checks its purity, undercontrol of a controller 112 and using a water quality sensor. The waterquality sensor, in embodiments, includes a conductivity sensor. Thewater purification module 102 utilizes one or more filter modules 130which are replaced to help maintain the ability to generate productwater that is sterile and ultra-pure. Product water 109 from the waterpurification module 102 is conveyed to a medicament proportioning module104 which mixes one or more concentrates provided in a replaceable fluidcircuit 132 to generate a medicament 111. The medicament concentrate arediluted in a predefined proportion to generate product medicament. Oneor more concentrate materials may be utilized and combined in theproduct medicament. The water purification and medicament generation areperformed in in-line fashion and on-demand, which means water ispurified and mixed with medicament concentrate as a continuous process,at a rate of consumption and as demanded by a final consumer, in thiscase, a cycler 106. Waste produced by the medicament proportioningmodule 104 is conveyed as indicated at 115 to a drain 117. Waste 110,for example spent medicament, is conveyed to the same or other drain117.

Each of the water purification module 102, the medicament proportioningmodule 104, and the cycler 106 may include a respective controller 112,114, and 116. All of the controllers 112, 114, and 116 may be incommunication as indicated by lines 122 and 124. In alternativeembodiments a smaller or larger number of controllers may be used andthey may be associated with each module 102, 104, 106 or shared amongthe modules 102, 104, 106. One or more user interfaces, figurativelyindicated at 101 and 103 may be connected to one, two, or the entirewater purification module 102, medicament proportioning module 104,and/or cycler 106. Connections between the user interfaces 101, 103,indicated at 123 and 125, may be wired or wireless. In embodiments,control may be provided through a single user interface 103 and eachmodule may transmit commands responsive to commands from the userinterface 103 to the respective controllers 112 and 114 of the waterpurification and medicament proportioning modules 102 and 104, inparallel or serially. In embodiments, the cycler 106 receives andreturns blood in arterial and venous lines 120A and 120B. In otherembodiments, medicament is conveyed to and from a patient, for examplein a peritoneal dialysis treatment.

FIG. 2 shows details of the water purification module of the embodimentof FIG. 1. Referring now to FIG. 2, a water purification module 102receives tap water from an inlet 214, the tap water being pumped by apump 212 and passed through a sediment filter 202, a water qualitysensor station 219, and an activated carbon filter 204. Water from theactivated carbon filter 204 is received by a two stage deionizationfiltration element 244 that includes a primary resin cation stage 205, aprimary resin cation stage 206 and a secondary mixed resin bed 208. Theprimary resin cation stage 205 and primary resin anion stage 206 may becombined in a single replaceable unit 242 or may be separatelyreplaceable. The primary resin cation stage 205, primary resin anionstage 206, and secondary mixed resin bed 28 may also be combined in asingle replaceable unit in alternative embodiments. Deionized water fromthe two stage deionization filtration element 244 passes through adiverter valve 230 which is controlled by a controller 240. The divertervalve 230 may selectively direct a flow of deionized water to a drainoutlet 232. Deionized water passing through the diverter valve for thegeneration of product water is directed to a heater 220, a degassingfilter 222, and two or more sterile filters connected in series to formsterile filter stage 210 from which product water may be drawn through aproduct water outlet 216. A vacuum pump 259 may be provided on an airside of the degassing filter 222. The degassing filter 222 may have ahydrophobic membrane to allow gas to be removed from water flowingthrough it.

The water quality sensor station 219 may output a signal indicatingwater quality, for example signal indicating conductivity of the water,which may be numerically cumulated by the controller to generate, forany point in time, a remaining life of any of the filters providedherein. The water quality sensor station 219 may include a particlecounter, a conductivity sensor, an optical opacity sensor, a pH sensor,or lab-on-a-chip chemical assay sensor, and/or other type of waterquality sensor. The user interface may allow the entry of other dataregarding water quality. For example, a worst-case upper bound, or datarelated thereto, of raw water constituents may be provided. An algorithmthat predicts the rate of the various components, based on a measuredindicator, may then be used to predict the rate of all contaminantconstituents. In an example embodiment, the algorithm may predict thatall contaminants are in the same proportion as a predefined value suchthat an indication of conductivity by the water quality sensor station219 may thereby indicate the concentrations of the various contaminants.In embodiments, the controller may output an indication of the remaininglife of the various components or an indication that a component is ator near expiration. In a particular embodiment, the useful life of thedeionization resin beds may be estimated based on conductivity indicatedby water quality sensor station 219. The estimation of the remaininglife may be based on the data carried by the data carrier of thereplaceable tagged component indicating characteristics such as thecapacity or type of decontaminating media employed thereby. The waterquality sensor station 219 may be positioned at any suitable pointdownstream of the inlet 214, even though shown downstream of thesediment filter 202.

The pump 212 and sediment filter 202 may form permanent orinfrequently-replaced components that are ordinarily not replaced by theuser. The entire WPM is adapted for use by a home-bound patient and/or ahelper although its features of compact size and low water volumerequirement make it attractive for use in critical care environments.The tap water inlet 214 may be fitted with an adapter suitable forconnection to an accessible permanent or temporary connection so that,for example in critical care environments, the water purification module102 may be wheeled to a point of use and connected to a nearby water tapwith such a connection fitting. In embodiments, the WPM is combined withthe medicament proportioning module 104 in a single housing so that itcan be wheeled to a point of use and/or compactly housed for use in ahome.

Each of the replaceable components (activated carbon filter 204, primaryresin cation stage 205, primary resin anion stage 206, primary resinanion stage 280, replaceable unit 242, or sterile filter stage 210) maybe fitted with a respective data carrier 201, 203, 209, 207, 211 such asa bar code or radio frequency identification RFID tag that carries aunique identifier respective to the attached component (again, attachedcomponent may be any of the activated carbon filter 204, primary resincation stage 205, primary resin anion stage 206, primary resin anionstage 280, replaceable unit 242, or sterile filter stage 210 and willgenerally be referred to as replaceable tagged component). Product watermay be drawn through the product water outlet 216.

A reader 245 may be attached to the purification module 102 and may bepositioned so as actively or passively to read the data carrier 201,203, 209, 207, 211 of the replaceable tagged component. Reader 245 maybe a scanner for an RFID, a bar code scanner, a smart chip reader, orany other type of data carrier reader and may connect optically,electromagnetically, electrically through conductive contacts, or by anyother suitable means. Note that although the term RFID is used, smarttag technology which is also identified as RFID can carry otherinformation besides identifiers. So as the term is used here, datacarriers carry any kind of information and RFID can also carry any typeof information and transmit the information wirelessly, and passively,to the reader 245 when the RFID device is brought into communicationrange of the reader 245. The data carriers 201, 203, 209, 207, 211provide various safety and convenience functions for purposes ofmaintenance and operation. For example, the reader 245 may be connectedto the housing of the water purification module 102, may read the datacarriers 201, 203, 209, 207, 211 automatically as they are installed orupon the carrying out a separate scanning step such as the moving of theattached component relative to a scanner.

FIGS. 3A and 3B illustrate an optional mechanism that may be providedwith a device 270 such as the water purification module 102, themedicament proportioning module 104, or any other similar mechanism thatreceives replaceable tagged components (i.e., ones having datacarriers). A mechanical actuator 275, three of which are illustrated inthe figures, selectively moves an interfering element 274 into and outof a loading path of a replaceable tagged component 272. Until a datacarrier of the replaceable tagged component 272 is read by a reader, theinterfering element 274 blocks the loading path as indicated by theinterfering element 276. Once the data carrier of the replaceable taggedcomponent 272 is read, the interfering element interfering element 276moves into the position shown at 274 of FIG. 3B thereby clearing theloading path and permitting the replaceable tagged component replaceabletagged component 272 to be installed as shown in FIG. 3B. A variety ofdifferent types of interfering elements may be provided, for example,one that makes the receiving bay 277 of the replaceable tagged componenttoo small to receive and changes configuration to make it large enoughto receive the replaceable tagged component. Other alternatives are alsopossible, for example, preventing use of the device 270 until thereplaceable tagged component 272 data carrier is properly read.

FIG. 4 shows a variant of the water purification module of theembodiment of FIG. 2 in which respective data carrier readers 251, 252,254, 255, 256, and 257 are provided. The readers 251, 252, 254, 255,256, and 257 may be positioned with respect to a housing of the waterpurification module 102 so that each receiving bay can automaticallyread a respective data carrier. Note that this arrangement may be usefulwhere the range of the reader 251, 252, 254, 255, 256, and 257 is veryrestricted, for example, a bar code laser scanner or conductive contactdevice for reading a smart chip is employed.

The information stored on data carriers (as in any of the embodiments)may allow the controller 240 to verify that the correct type ofreplaceable tagged component 272 is installed. The controller 240 maydetect the removal or disconnection of a replaceable tagged component272 as well. In an embodiment, the controller 240 may generate a refusesignal and take corrective action (such as preventing use of the waterpurification module 102 or blocking installation of the replaceabletagged component 272 or some other action). Referring now to FIG. 5, ina method implemented by the controller 240 (or by controllers of any ofthe embodiments employing replaceable tagged components), the removal ofa replaceable tagged component 272 is detected (S10). The removal may bedetected by the fluid line disconnection of the replaceable taggedcomponent 272, by the movement of the replaceable tagged component 272to a remote location, or by the displacement of the replaceable taggedcomponent 272 relative to a reader such as a bar code scanner or RFIDreader. At S12, if the replaceable tagged component 272 is determined tohave been removed S14, a time of removal is recorded in a data storageaccessible to the controller 240 (S14) and if not, control passes toS16. At S14, a unique identifier of the replaceable tagged component 272may be recorded along with the time of removal.

In alternative embodiments, a data carrier on the replaceable taggedcomponent 272 may be updated to include an indicator that thereplaceable tagged component 272 was disconnected and the time ofdisconnection. At S16, the controller 240 detects the installation of areplaceable tagged component 272 and if one has been installed, it isidentified at S20 (or in alternative embodiments, the attached datacarrier is read to determine the time of disconnection). At S20, thecomponent is identified and if at S22 it was previously installed, thetime of disconnection is determined at S22 by reading data from the datastore corresponding to the identity of the replaceable tagged component272. The length of the disconnected interval of the replaceable taggedcomponent 272 is determined at S24 and if it exceeds a predefinedthreshold stored by the controller 240, a refusal signal is generated atS28; otherwise a permission signal is generated at S26. In response tothe permission or refuse signal, the controller may prevent use of theinstalled replaceable tagged component 272 by any of the mechanismsdescribed herein. At S34, the controller 240 may identify any othertypes of red flags. For example, it may determine if the replaceabletagged component 272 has been expired or otherwise indicated atunsuitable for use and if so, at S34, a refuse signal may be generatedat S28.

At S32, in embodiments, the controller 240 may determine from the datacarrier attached to the replaceable tagged component 272 whether thelatter has been previously used, for example, on a different system orthe same system. It may further permit or allow reuse based on criteria,such as whether the system (e.g., water purification module 102) was aknown system, for example, one that is used in a particular treatmentfacility and therefore a home system subject to identical use protocols,or an alien or unknown system. The data carrier attached to thereplaceable tagged component 272 may also store use history informationsuch as date of first use, number of water purification modules 102 ithas been installed on, time since last use, etc. The controller may beprogrammed to permit or refuse based on an algorithm applied to theseinput data.

An operation S29 may be included in which the controller 240 downloadsdata indicating the use history of the replaceable tagged component 272and calculates whether it is permissible to be used according to somepredetermined formula. The use history may contain volume of fluidprocessed, time remaining before an expiration date, and/or other dataindicative of wear and tear on a replaceable tagged component 272. Atime at which a replaceable tagged component 272 was disconnected orfirst wetted may be determined by looking up data stored locally or onan Internet-accessible data service (S23). These data may be used topermit or prevent the use of a replaceable tagged component 272.

The controller 240 may further be programmed to determine if thereplaceable tagged component 272 that is being connected is a correcttype of device for the water purification module 102 (or other type ofsystem using the replaceable tagged component 272). To this end, thedata carrier attached to the replaceable tagged component 272 may storea product class that identifies the type of device. A scanner local tothe receiving bay (as in FIG. 4 embodiment) may scan the data carrierand determine, based on the particular receiving bay on which it isinstalled, whether the correct type of replaceable tagged component 272is being loaded.

In embodiments, replaceable tagged components 272 have fluid connectorswith leads. In FIGS. 6A-6C, a replaceable tagged component 272 is shownat 302. The replaceable tagged component 302 has a fluid connector 306with electrically conductive connector portion 330 that permits a datacarrier 316 to communicate, when connected, with the controller 240 ofthe water purification module 102. The controller connects through aconductive contact 328 on a connector 308 of the water purificationmodule 102 embodiment indicated at 270 supported by a fluid circuitsupport 312. The water purification module 270 has a support 304 toreceive the replaceable tagged component 302. When the replaceabletagged component 302 is positioned in its support 304, the connectors306 and 308 can be connected fluidly and, simultaneously, electricallyso that the replaceable tagged component 302 is connected fluidly to thewater treatment module 270 and the data carrier 316 is connectedelectrically to the controller 240. As indicated at 334, conductivewiring can be attached along a fluid line 318. The electrical connectorportions 328 and 330 may connect multiple conductors for transfer ofsignals as well supplying power. In alternative embodiments, the datacarrier 316 may include an RFID or smart chip that communicateswirelessly with the controller 240, in this case fitted with atransceiver or receiver. Other alternative embodiments may employ barcode readers.

Data carriers of the above and below embodiments in which replaceabletagged component 272 are used may include the following data to supportfunctionality described herein.

-   -   i. The type of replaceable tagged component 272 correct canister        is loaded into the hardware identified by a unique class        identifier, which may also include model number, date of        manufacture or lot number, and identifier of manufacturer.    -   ii. A unique identifier of the replaceable tagged component 272        such as a serial number.    -   iii. Disposable status including, for example, expired,        exhausted, new, and used.    -   iv. Allowed uses for the replaceable tagged component.    -   v. A log of error conditions encountered by the replaceable        tagged component 272. The list may be generated by the water        purification module 102 or other machine into which the        replaceable tagged component 272 has historically been        installed.    -   vi. A list of requirements for use of the replaceable tagged        component 272, such as upstream fluid conditions or pressure        limitations.    -   vii. A list of prior users and/or devices each uniquely        identified by a code.    -   viii. A complaint-report identifier that can be matched against        a log of complaints for similar replaceable tagged components        272 and others.    -   ix. A log of conditions that may indicate risk of failure such        as surpassed pressure limits, temperature limits, usage cycles,        and incomplete fluid processing cycles.

FIG. 7 shows an overview of an online water purification, proportioningmedicament generation, and treatment system 351. The water purificationmodule 102 and medicament proportioning module 104 form a medicamentgeneration system 355 and are commonly housed in a housing 350 with auser interface 101. The cycler 356 (or generally, a medical treatmentdevice that consumes medicament generated by the medicament generationsystem 355) may form a separately housed device that is signally andfluid connected to the medicament generation system 355. Communicationsmodule 358 interconnects the controllers 304 and 116 of the medicamentgeneration system 355 and cycler 356 respectively.

By combining the medicament generation system 355 with a cycler, asystem suitable for use in a home, critical care, or clinic may beprovided without a need for specialized services such as high capacitymunicipal water supply, power, or drainage. For example, high volumewater supply is typically required in reverse osmosis-based waterpurification system. In the present embodiments, municipal water 360 isdeionized using consumable deionization filter beds, allowing normalrates of water flow and drainage 317 in a services supply 362 that istypical of a home or the room services of a hospital. With power 360requirements at residential or typical hospital-room voltages andcurrents, available services allow the proportioning medicamentgeneration, and treatment system 351 to be used for home and criticalcare, as well as in clinics. For clinics, the rapid set-up of a newinstallation can be facilitated as well because expensive capitalinfrastructure of an online medicament generation system can be avoided.

As in the embodiment of FIG. 1, the water purification module 102receives tap water 108 from a municipal water supply. The waterpurification module 102 purifies the water and checks its purity undercontrol of controller 304. The water purification module 102 utilizesone or more filter modules 130 which are replaced to help maintain itsability to generate product water that is sterile and ultra-pure.Product water 109 from the water purification module 102 is conveyed toa medicament proportioning module 104 which mixes concentrates providedin a replaceable fluid circuit 132 in a predefined proportion togenerate a medicament 311. The water purification and medicamentgeneration are performed in on-line fashion and on-demand, which meanswater is purified and mixed with medicament concentrate as a continuousprocess, at a rate of consumption and as demanded by a final consumer,in this case, a cycler 356. Waste produced by the medicamentproportioning module 104 is conveyed as indicated at 115 to a drain 317.Waste 110, for example spent medicament, is conveyed to the same drainor another drain 317. The cycler 356 may be of any type includinghemodialysis and peritoneal dialysis as well as other types of treatmentsystems.

The function of the communication module may allow the controller 116 tosend specific command signals to the medicament generation system 355,for example, to start and stop medicament generation. In a system inwhich the cycler 356 is not adapted to send specific commands, a statusvector can be translated by the communications module 358 to convert itto one or more suitable commands. A status vector may includeinformation such as whether a blood pump of the cycler 356 is running.

Service computer 364 and 366 may communicate, respectively, with themedicament generation system 355 and cycler 356. The controllers 304 and116 may generate operation or treatment logs and/or maintenanceinformation which they may send the service computer 366 for furtherdistillation, synthesis, storage, or communication to other facilitiesand/or remote professional care management or maintenance personnel.

FIG. 8A shows details of an embodiment of medicament proportioningmodule 104. A sealed fluid circuit 401 is partially supported by acartridge support 406. Flow lines supported by the cartridge support406, shown generally at 408 may be tubes attached to the cartridgesupport 406 or formed therein by molded and sealed channels or inattached seam-welded flexible panels or by other suitable means. Thesealed fluid circuit 401 may also include all the other lines and fluidcircuit elements illustrated including such as waste line 422, inletline 431, medicament concentrate lines 433, product medicament line 435,control valve 420, junction 437, and inlet sterile filter 445 to form asingle pre-connected sterile disposable unit along with the flow lines408 (and other elements supported by the cartridge support 406 describedbelow). As explained, the entire sealed fluid circuit 401 shown in FIG.8A, save for the inlet line 431 inlet and product medicament line 435are pre-connected and sealed from the external environment. The sealedfluid circuit 401 may be sterilized as a unit, for example, gammasterilized or heat sterilized.

A source of pure water can be connected by way of a connector 414 whichis capped and sterile-sealed prior to connection. By sterile-sealed itis meant that a seal is formed sufficient to physically block anycontaminants from entering. A sterile filter 445 insures that anycontamination in the flow, for example resulting from touchcontamination or a contaminated connector on the pure water source istrapped by the sterile filter 445. Thus, sterile filter 445 forms partof the complete sterile barrier such that the entire sealed fluidcircuit 401 has a continuous sterile barrier even after the connector414 is unsealed, at least while the product medicament line 435connector 421 is capped. The sterile filter may be one with a 0.2 μmmembrane to block bacterial contaminants. Note that by ensuringcompletely sterile deionized water flows into inlet line 431 and becausethe entire sealed fluid circuit 401 is sealed and sterile, the unit onceset up and ready for treatment can be filled and used over an extendedtreatment without the risk of proliferation of contaminants. Forexample, the sealed fluid circuit 401 can be prepared for use and primedand used, up to 24 hours later. Alternatively it may be used for morethan one treatment.

Pure water flows through the sterile filter 445 at a rate of pumpingdetermined by the pump 442. Sterile water also may be drawn through theproduct water inlet 431 and the filter 445, via the junction 419, bymedicament concentrate pump 444 to generate the saturated medicamentconcentrate container 429 through a water branch line 451. To match therate of production of purified water with the rate of pumping by pump442, the source of purified water may generate a constant supply into anaccumulator, it may pump continuously with overflow to a drain, or apump of the water purification module 102 may be commanded in responseto the controller 402 of the medicament proportioning module 104. Acontrol valve 449, which may be a pinch clamp or any other type ofcontrol valve, may be controlled to prevent a reverse flow of water fromthe dry medicament cartridge 447. In alternative embodiments, a checkvalve may be used in place of control valve 449. Reference numerals inFIG. 8B not otherwise discussed are as shown and discussed withreference to FIG. 8A where they identify the same elements in FIG. 8B.Reference numeral 432 indicates that a single concentrate, such aslactate buffered dialysate, can be substituted for themultiple-component concentrate. This is true of any of the embodiments.

Referring to FIG. 8C, for example, a pump 191 may be a positivedisplacement pump that is controlled as a slave by a controller 193 of amedicament proportioning module. Pure water flows through the connection196 on-demand. A controller 192 of the water purification module maycontrol the pump 191 directly to ensure that water flows at a rate atwhich it is commanded by the controller 193. Alternatively a singlecontroller 193 can control pump 191. The pump 194 belongs to themedicament proportioning module and is used for regulating the flow ofwater for the dilution of water concentrate to generate medicament. Inthis and any of the other embodiments of FIGS. 8C through 8G, the singlepump 191 can regulate the flow of water through the medicamentproportioning module, avoiding the need for a separate pump 194 or 191.Referring to FIG. 8D, water purification module pump 191 is controlledby controller 192 and maintains a pressure in the junction 196determined by a cracking pressure of a check valve 187. The pump 191 maybe controlled as discussed in the previous embodiment, with thearrangement here providing a compliance that may not be present in theprevious embodiments because any overshoot of the pump 191 can beaccommodated by overflow through the check valve 187. Referring to FIG.8E, a similar arrangement as that of FIG. 8D recirculates any overflowwater back through the pump 191 through a recirculating line 198. Thisalso maintains a predefined pressure at the junction 196 and allows thepump 191 to run without wasting water. Note that it may be possible toplace the pumping arrangements at any point in the water purificationmodule flow path so that unpurified water, partially purified water, orpurified water is pumped by pump 191.

FIG. 8F shows an arrangement that is similar to that of FIG. 8C, exceptthat in the embodiment of FIG. 8F, compliance may be provided by anaccumulator 181 and pressure may be monitored by way of a pressuretransducer 179 in the connection 196 fluid channel. The pressure sensorcan be located upstream or downstream of the accumulator 181. Thecontroller 192 may detect a current pressure and regulate the pump 191to maintain a range of pressures that accommodates a mismatch betweenthe rates of pumps 191 and 194 or a delay in the regulation of one orboth of the pumps 191 and 194 responsively to commands from thecontroller 193. As the pump 194 draws down the volume of the accumulator181, the pressure falls therein, which is detected by the pressuretransducer 179. The pressure signal is applied to the controller 193. Inresponse to the fall in pressure, the controller 192 causes the pump 191to pump to try to restore the target pressure in the accumulator 181.Thus, the operation of the pump 194 may indirectly control the operationof pump 191 as a pressure signal through the accumulator 181. Theaccumulator 181 may be of the configuration discussed with reference toFIGS. 8H and 8J. The pump 191 may be one or more pumps that arecontrolled to proportion water and medicament concentrate. Wherepressure of the accumulator is used to control pumping of pump 191,there is no need for a signal line 195 or direct signal control of pump191 by controller 193.

A variant of this arrangement is also shown in FIG. 8G in which anaccumulator tank with one or more level indicators 177 that indicate afluid level in the tank 183. Controller 192 may be regulated to maintaina predefined level or range of levels of the tank 183 such that as fluidis demanded by the pump 194, the demand can be immediately accommodated.Pump 191 is regulated by the controller 192 to fill the tank when thelevel is below a desired level and to stop when filled to a desiredlevel. Alternatively the pump may be servo-controlled to maintain afixed level only when a demand for water is received from the controller193 by the controller 192. The mechanisms of FIGS. 8C through 8G may beadapted by incorporating them in a separate module between the waterpurification module 102 and medicament proportioning module 104 or inone or the of the water purification module 102 and medicamentproportioning module 104 to form further embodiments.

The interfaces of FIGS. 8C through 8G may be used to interconnect awater purification module 102 with a medicament proportioning module104. Alternatively, any of them may be used to interconnect a medicamentproportioning module 104 with a cycler 106 or other consumer ofmedicament. These may be used to modify any of the disclosedembodiments.

Referring now to FIG. 8H, medicament proportioning system 170 has acontroller 153 that controls one or more pumps 158. The one or morepumps 158 conveys medicament through a product medicament supply line149 which is connected (by connectors 161) to a downstream medicamentconsuming device 157 that draws product medicament using at least onepump 159. The medicament consuming device 157 may be an extracorporealblood processing system (with a blood treatment component 152) such as adialysis system or any of the other medicament consuming devicesmentioned in the instant disclosure. In many medicament consuming device157 the demand for medicament may be intermittent, irregular, orotherwise variable. For example, the medicament consuming device 157 maydraw fluid in a bolus with a brief pause or it may have a flow profilethat periodically and progressively peaks and troughs between maximumand minimum values. However, for various reasons, it may be desired tooperate the one or more pumps 158 at a more constant or slowly-varyingrate. The reasons may include a need or desire for more accurateproportioning of water and medicament concentrate in in-line medicamentproportioning systems such as medicament proportioning system 170. Forexample, in some hemodialysis systems, the medicament is drawn by afluid balancing component that draws medicament in steps. Examplesinclude known volumetric fluid balancing components of hemodialysissystem systems used for balancing the flow of fresh dialysate againstspent dialysate throughout a treatment. A fluid circuit 168 has anaccumulator 164 integrated therein. The accumulator 164 may be attachedto, or integrated in, a cartridge indicated figuratively at 168, forexample as in many of the embodiments described in the presentdisclosure. The medicament proportioning system 170 fluid circuit 168 orother fluid circuit may have sensors and actuator portions 167 thatengage with and sensors and actuators 175 of the medicamentproportioning system 170.

The accumulator 164 includes a flow chamber housing 163 with an internalvolume 162. Product medicament flows through the internal volume 162.Product medicament may flow into an inlet 171 and out from an outlet 172defining a continuous flow path through the internal volume 162. Theinterior volume 162 is sealed by a chamber-wall film 173 which may be ofthe same type as provided for sealing the trough-shaped channels offluid circuit cartridge embodiments described herein and in the claims.Thus, the chamber-wall film 173 may be adhered by welding or adhesive orany other suitable method to a perimeter region 164 of the flow chamberhousing 163. To make the chamber-wall film 173 larger in area, followingthe attachment of the chamber-wall film, it may be stretched by heatingand forcing a boss (not shown) into the chamber-wall film 173, which maybe shaped as the interior volume 162 or any other shape or size suitablefor stretching the chamber-wall film 173. Note that the chamber-wallfilm 173 may be made of highly elastic material and may not need to bestretched at all. In embodiments, the trough-shaped channels (seediscussion and examples throughout the specification) are sealed withthe same type of film used for the chamber-wall film 173.

The accumulator 164 chamber-wall film 173 engages a forcing module 160during use. In FIG. 8H the forcing module 160 is shown relativelyretracted from the accumulator 164. FIG. 8J shows the forcing module 160positioned against the accumulator 164 as it would be during operation.The forcing module 160 has an elastic web 174 supported by a button 169which is urged by an urging element 165 such as a spring. The button 169floats (i.e., it is unsupported by a bearing or slide) so that there isno frictional loss due to sliding or rolling supports so as to minimizeany hysteresis or frictional component to pressure generated in theinterior volume 162. In use, the interior volume 162 pressure isdetermined by the constant of urging element, for example by the springconstant. Thus a progressive change of pressure with volume may beprovided which is repeatable and does not depend on variation due tomanufacturing tolerances of the accumulator 164 or fluid circuit (e.g.cartridge) 168 of which it is a part. The elastic web 174 may be ofneoprene or elastomer, or some other suitable material. Duringoperation, the urging element 165 would expand and contract as theinterior volume 162 changes. Note that in embodiments, it may bedesirable for the button to be a larger fraction of the facing area ofthe interior volume 162 to minimize the contribution of the elasticproperties of the elastic web 174 and chamber-wall film 173 to thevolume-versus-pressure properties of the interior volume 162.

A pressure transducer 155 receives pressure signals from the productmedicament channel 166 and conveys them to controller 153 of themedicament proportioning system 170. The pressure transducer 155 may beconnected to the accumulator directly in alternative embodiments. Inembodiments discussed relative to FIG. 17, the pressure transducer maybe a strain gauge that is forced against a fluid channel formed in abase element of a cartridge and closed by a film, the film pushing onthe strain gauge to generate the pressure signal (See discussion of FIG.17, reference numerals 847, 848 and channels 826 and methods offorming.) Note that controllers 153 and 151 may be distributed amongcomponents in any suitable fashion and the medicament proportioningsystem 170 and the medicament consuming device 157 may be combinedand/or controlled by a single controller in alternative embodiments. Asthe medicament consuming device 157 demands fluid by pumping from theinterior volume 162 by causing a reduced pressure by means of the atleast one pump 159, the change in pressure causes a reduction in volumeof the interior volume 162 and the pressure change is indicated to thecontroller 153 by the pressure transducer 155. The controller 153 mayhave a servo program or proportion, integral, differential controldevice or any other suitable device for causing the one or more pumps158 to operation continuously to maintain a predefined minimum volume ofproduct medicament in the interior volume 162. For example, it may usean integral-dominated algorithm to smooth the changes in pressure andcontrol by an average pressure in the interior volume 162 toward aconstant pump speed or a slowly varying pump speed.

The size of the accumulator 164 internal volume 162 may be selectedbased on the variability of the demand in order to minimize theaccumulator internal volume 162. The selected volume may be selectedbased on a survey of all the operating conditions of the medicamentconsuming device 157, internal compliance of all connected fluidchannels between the accumulator 164 and the medicament consuming device157 as well as the characteristics of the pressure transducer and thefeedback control algorithm used to regulate the steady pumping rate 158of the medicament proportioning system 170 (i.e. one or more pumps 158).Note that the one or more pumps 158 may include a water pump and one ormore medicament pumps which together determine the flow rate into theproduct medicament channel 166. In embodiments, the size of the internalvolume is a minimum volume required to allow the one or more pumps 158to be operated at a constant speed (i.e., all of the contributing pumpsof one or more pumps 158 may operate at constant speeds) at alloperating conditions of the medicament consuming device 157. Note thatby “constant speed” it should be understood that this refers to theaverage rate which may vary but on a time scale that is less than thetime scale of periodic variability of the medicament consuming device157. So over, for example, the average rate of flow of medicamentthrough medicament consuming device 157 may be constant during a oneminute period early during a treatment and may be lower or higher duringa one minute period later or earlier in the same treatment, but duringeach minute, there may be periodic fluctuations in flow rate that areaccommodated by the accumulator 164. A first characteristic of thevariability that drives the selection of characteristics the accumulator164 is that the variability is of a much shorter time scale that thetime scale of a treatment, for example, a hundredth or a thousandth ofthe time scale of the treatment. Another is that it is periodic (goes upand down and back up again, cyclically and predictably). Anothercharacteristic is that the variability is due to a mechanicalcharacteristic of a pumping mechanism of the medicament consuming device157.

The embodiment of FIG. 8H, 8J, which may be incorporated in any of thedisclosed embodiments or combined with features of the claims to formnew embodiments. The embodiment may be a feature of a medicament supplysystem, a medicament proportioning module 104 of a system that includesor doesn't include a plant for purification of water. It will beobserved that this embodiment provides a forcing module 160 that ensuresa progressive change in pressure with volume and preferably one thatapproximates the linearity of the urging element 165, for example aspring constant. The forcing module applies a force from a passivecomponent (spring) whose shape is changed in response to changes inpressure which change of shape results in a predictable, repeatable,volume-versus-pressure characteristic of the interior volume 162. Afeature of the forcing module is that no bearing surfaces are requiredto be engaged. These features can help to make the pressure-volumeresponse linear. In alternative embodiments, the pressure-volumerelationship may be other smoothly varying progressive functions thatpermit a flow rate upstream to be constant, or smoothly varying so as topermit accurate proportioning of missed component fluids as described.The use of an elastic wall 173 and an elastic web 174 can avoid the needfor a bearing, but the elastic changes (e.g., stretching) and shapechanges can affect the pressure-versus-volume characteristics of theinterior volume 162. This may introduce material or variation due tomanufacturing tolerances that may affect regulation of the pump speed.The use of the button 169 and urging element 165 and the selection of aweb 174 and elastic wall 173 material and dimensions to minimize theircontribution to the restoring force ensure that the pressure-volumecharacteristic of the interior volume 162 is predictable. Inembodiments, the pressure-volume state diagram of the interior volume162 is linear and exhibits essentially no hysteresis. In embodiments,the interior volume 162 (or the displaced volume over the full range oftravel of the elastic wall 173) is selected to be a predetermined ratioabove the minimum required to allow for constant (again, constant withinthe lower time scale) flow rates of controller 153) based on apredefined medicament consuming device 157, compliance of connectedchannels, and a predefined algorithm, sensor response, and othercharacteristics of the regulated system. The predefined ratio may beless than 2, effectively specifying that the displaced volume no morethan twice the minimum necessary to provide for constant rates ofpumping by the one or more pumps 158. A common example of a medicamentconsuming device 157 having variable rates of pumping is a volumetricbalancing system that alternately fills and drains one or more chambersto achieve an average-balanced flow rate. Note that the embodiment ofFIGS. 8H and 8J may be used in combination with any of the embodimentsdisclosed herein. It will be noted that by controlling the one or morepumps 158 responsively to a pressure of the transducer 155, effectivelya mechanical command signal may be transmitted by the medicamentconsuming device 157 pump at least one pump 159. That is, as themedicament consuming device 157 pump at least one pump 159 draws downthe volume of the accumulator 164, the servo-control of the one or morepumps 158 responds through the pressure signal of transducer 155 tomaintain the average volume of interior volume 162. Thus, inembodiments, the medicament proportioning system 170 and medicamentconsuming device 157 may be mechanically coupled without providing acontrol interface to regulate flow.

In alternative embodiments, the volume of 162 is actively controlled byan active actuator in place of urging element 165 in response to changesin a detected volume. For example, a displacement encoder could beconnected to a linear motor used in place of urging element 165. In suchan embodiment, volume feedback control may be used to maintain anaverage target volume in the internal volume 162.

Referring again to FIG. 8A, the cartridge support 406 may be received ina medicament proportioning module 104 which may further be stand-aloneunit or combined with a water purification module 102. As illustrated,the medicament proportioning module 104 is a stand-alone unit. Purifiedwater is received at an inlet 431, which forms a part of a disposablesterile fluid circuit that includes all the fluid lines and circuitcomponents illustrated in the figure and/or discussed herein. Pump 442pumps water that flows at a rate controlled by a controller 402. Pumps44 and 446 regulate flows of respective medicaments concentrates inmedicament concentrate lines 433 so that they are diluted in a preciselycontrolled ratio by the flow of water pumped by the pump 442. A firstconcentrate in container 428 pumped by pump 444 is combined in junction437 with the flow of water pumped by pump 442, thereafter flowing into aconductivity measurement module 415 which generates a signal indicativeof the concentration of medicament concentrate in the mixture emergingfrom the junction 437. A temperature signal indicating a temperature ofthe same flow is also generated by a temperature transducer 413. Thesignals indicating conductivity and temperature are applied to thecontroller 402 which converts them to concentration responsively tostored (in a data store of the controller—not shown separately)conductivity-temperature curves for the solution of the diluted firstconcentrate stored in the container 428. A secondary set of conductivitymeasurement module and temperature transducer 416 and 412 may beprovided to provide signals indicating conductivity and temperature ofthe same flow as a confirmation. If the calculated concentrationsdiffer, the controller 402 may generate a signal indicating acorresponding error condition. In response the controller 402 maygenerate an error indication on a user interface 405 or halt the flow ofmedicament, or divert it through a diverting valve 420 to a waste line422, for example.

The second medicament concentrate is pumped by pump 446 from container430 into a junction 423 so that the second concentrate is mixed with thediluted first concentrate. The diluted and mixed first and secondconcentrates flow into a conductivity measurement module 417 whichgenerates a signal indicative of the concentration of medicamentconcentrate in the mixture emerging from the junction 423. A temperaturesignal indicating a temperature of the same flow is also generated by atemperature transducer 411. The signals indicating conductivity andtemperature are applied to the controller 402 which converts them toconcentration responsively to stored (in a data store of thecontroller—not shown separately) conductivity-temperature curves for thesolution of the diluted first and second concentrates. A secondary setof conductivity measurement module and temperature transducer 418 and410 may be provided to provide signals indicating conductivity andtemperature of the same flow as a confirmation. If the calculatedconcentrations differ, the controller 402 may generate a signalindicating a corresponding error condition. A final medicament productconcentration flows through the line indicated at 408 into anaccumulator 404 which has an expandable volume whose pressure may besubstantially determined by a spring constant due to a spring-basedrestoring force (See discussion of details of an embodiment below andembodiment of FIGS. 8H and 8J). A connected device, such as cycler 106can draw medicament through line 435. A cap 421 ensures a sterile outputline and is removed before connection.

Referring now to FIG. 8B, an embodiment of medicament proportioningmodule 104 differs from that of FIG. 8B in that a concentrate of acomponent medicament is formed from a dry material by dissolving iteither at once or progressively according to embodiments. In a preferredconfiguration, a bicarbonate buffer is stored in a cartridge 419 intowhich incoming purified water is diverted by a junction 419 such that itflows through a bed of dry bicarbonate to form a saturated concentratein the outlet line 433 drawn by pump 444. A single concentrate component432, such as lactate buffered dialysate concentrate, may be used for thegeneration of medicament as indicated to form further embodiments, inplace of the multiple component embodiments discussed.

FIG. 9A shows a disposable 464A including a fluid circuit cartridge andconcentrate containers according to embodiments of the disclosed subjectmatter. The concentrate containers 460 and 462 may correspond tocontainers 429 and 430 in the foregoing embodiments of FIGS. 8A and 8B.In the example of FIG. 9A, the concentrate containers contain liquidmedicament concentrate. An example composition, which may include anynumber of concentrate components, is acid and a buffer such asbicarbonate or lactate. Bicarbonate may be provided in a dry form asillustrated in the further embodiments below. Peritoneal dialysate mayhave a third component such as glucose or preferably a mixture ofelectrolyte and glucose to allow concentration to be more easilycalculate from a conductivity signal as discussed above. The concentratecontainers 460 and 462 may be pre-connected with the rest of the sealedfluid circuit 470A including the cartridge 450. The concentratecontainers 460 and 462 may be packaged with the rest of the sealed fluidcircuit 470A including the cartridge as illustrated at 450. Theconcentrate containers 460 and 462 may be pre-connected with all inletand outlet line 473, 475 connections sealed and capped. As describedabove, the cartridge 450 may have conductivity 456 and temperature 452sensors, an accumulator 454 and other elements. The cartridge 450 mayalso have tube pumping segments 465 that are aligned with pump actuators(such as peristaltic pump rollers) when the cartridge 450 is positionedwith respect to the medicament proportioning module 104. The fluidcircuit 470A, including containers 460, 462 and cartridge 450 and anyother components required to make up the disclosed embodiments may bepackaged in a container 484 such as a box or bag.

In use, the cartridge may be removed from the container 484 andpositioned in the medicament proportioning module 104. The containers460 and 462 (and others if present, depending on the number ofcomponents) can remain in the container or box 484. Any flexible tubesremain interconnected such as tubes 466 and 468. The water inlet line473 can be uncapped and attached to the water purification module 102and the water outlet line 480 can be uncapped and attached to the inletof the cycler 106. In this way, minimal handling of the individualcomponents can result in the set of the medicament proportioning module104. In embodiments, the cartridge 450 can be separately packaged, forexample in a plastic bag, and attached to the outside of a box withinwhich the containers 460 and 462 are held.

FIG. 9B shows a disposable 464B including a fluid circuit cartridge andconcentrate containers as well as a dry solute container according toembodiments of the disclosed subject matter. The concentrate container460 contains a liquid concentrate. The container 482 is an emptycontainer. A cartridge 481 contains a dry solute that is diluted withpure water which fills the container 482 to make a concentrate. Thecontainers 460 and 482 may correspond to containers 429 and 430 in theforegoing embodiments of FIGS. 8A and 8B. The example constituents areotherwise as described with respect to FIG. 9A including the variations.The concentrate containers 460 and 482 and the cartridge 481 may bepre-connected with the rest of the sealed fluid circuit 470B includingthe cartridge 450. The concentrate containers 460 and 482 and thecartridge 481 may be packaged with the rest of the sealed fluid circuit470B including the cartridge as illustrated at 450. The concentratecontainers 460 and 482 may be pre-connected with all inlet and outletline 473, 475 connections sealed and capped. As described above, thecartridge 450 may have conductivity 456 and temperature 452 sensors, anaccumulator 454 and other elements. The cartridge 450 may also have tubepumping segments 465 that are aligned with pump actuators (such asperistaltic pump rollers) when the cartridge 450 is positioned withrespect to the medicament proportioning module 104. The fluid circuit470B, including containers 460, 462 and cartridge 450 and any othercomponents required to make up the disclosed embodiments may be packagedin a container 484 such as a box or bag.

In use, the cartridge may be removed from the container 484 andpositioned in the medicament proportioning module 104. The containers460 and 482 and the cartridge 481 (and others if present, depending onthe number of components) can remain in the container or box 484. Anyflexible tubes remain interconnected such as tubes 466 and 468. Thewater inlet line 473 can be uncapped and attached to the waterpurification module 102 and the water outlet line 480 can be uncappedand attached to the inlet of the cycler 106. In this way, minimalhandling of the individual components can result in the set of themedicament proportioning module 104. Water may flow into the line 480through the cartridge 481 propelled by a pump that engages with apumping segment 489 to prepare concentrate in container 482. Inembodiments, the pumping segment 489 may be attached to the cartridgewith other pumping segments as discussed with reference to FIG. 10,infra. In embodiments, instead of providing a separate cartridge, a drysolute may be stored in the container 482. In any of these embodiments,the contents of the container 482 may be mixed by continuousrecirculating pumping using an additional branching line and pump (notshown). In embodiments, the cartridge 450 can be separately packaged,for example in a plastic bag, and attached to the outside of a boxwithin which the containers 460 and 462 and cartridge 481 are held.

FIG. 9C shows a disposable 464C including a fluid circuit cartridge andconcentrate containers, one of the concentrate containers beingconnected to dilute saturate an inline applied flow of water to generatea concentrate, according to embodiments of the disclosed subject matter.The concentrate container 460 contains a liquid concentrate. Thecontainer 483 is a cartridge of a type that receives water at an inlet480 and produces a saturated solution from dry solute stored in thecartridge in the line 468. This type of cartridge is of a known type andtypically used for bicarbonate solution generation for dialysatesystems. The container 460 and cartridge 483 may correspond tocontainers 429 and 430 in the foregoing embodiments of FIGS. 8A and 8Bin that fluid is drawn from them in the manner described. The exampleconstituents are otherwise as described with respect to FIG. 9Aincluding the variations. The concentrate container 460 and cartridge483 may be pre-connected with the rest of the sealed fluid circuit 470Cand sterilized after sealing. The concentrate container 460 andcartridge 483 may be packaged with the rest of the sealed fluid circuit470C. The fluid circuit 470C may be pre-connected with all inlet andoutlet line 473, 475 connections sealed and capped. As described above,the cartridge 450 may have conductivity 456 and temperature 452 sensors,an accumulator 454 and other elements. The cartridge 450 may also havetube pumping segments 465 that are aligned with pump actuators (such asperistaltic pump rollers) when the cartridge 450 is positioned withrespect to the medicament proportioning module 104. The fluid circuit470B, including container 460 and cartridge 483 and any other componentsrequired to make up the disclosed embodiments may be packaged in acontainer 484 such as a box or bag. In the foregoing embodiments 464A,464B, and 464C, a water sterilizing filter 519 may be provided tosafeguard against touch contamination in connecting the disposable 464A,464B, and 464C to a water purification module 102.

In use, the cartridge may be removed from the container 484 andpositioned in the medicament proportioning module 104. The container 460and cartridge 483 (and others if present, depending on the number ofcomponents) can remain in the container or box 484. Any flexible tubesremain interconnected such as tubes 466 and 468. The water inlet line473 can be uncapped and attached to the water purification module 102and the water outlet line 480 can be uncapped and attached to the inletof the cycler 106. In this way, minimal handling of the individualcomponents can result in the set of the medicament proportioning module104. In embodiments, the cartridge 450 can be separately packaged, forexample in a plastic bag, and attached to the outside of a box withinwhich the container 460 and cartridge 483 are held.

Referring now to FIG. 10, an embodiment of a fluid circuit cartridge 500may be substituted for any similar device described herein, includingcartridge 450 of FIGS. 9A through 9C, cartridge 406 of FIGS. 8A and 8Band any fluid circuits incorporating the elements of cartridge 500 ofFIG. 10 such as the fluid circuits of the medicament proportioningmodule 104 of any of the foregoing embodiments. The cartridge has agenerally planar support 529 for the various fluid circuit elements. Inembodiments a fluid circuit is embodied in by a fluid circuit patterndefined in the support 529, for example by molded channels or seamwelding or a combination thereof. Alternatively the fluid circuit may bemade up of discrete channel elements such as tubes, junctions, andvalves. A fluid circuit 533 supported by the support 529 has channelelements 503 (indicated at 503 but also appearing at various locationsas indicated), temperature measurement cells 504, 507, 508, 511concentration measurement modules 535A, 535B, 535C, and 535D, pumpingtube segments 526, 527, 528, an accumulator 502, pinch valve tubesegments 522, 523, junctions 501, 509. Cutouts 513 in the support 529allow pumping actuators 532, 531, 530 to mechanically access pumpingtube segments 526, 527, 528, respectively, and valve actuators 536, 537to access pinch valve tube segments 522, 523 in order to pump fluid orhalt or allow the flow of fluid.

Pure water enters in line 541 from a water purification module 102pumped by pumping actuator 532 through pumping tube segment 526. Aninline sterile filter 515 ensures that any touch contamination, or anycontamination, does not enter the cartridge fluid circuit. Pumping tubesegment 526 (as well as segments 527 and 528) may of a specializedconstruction and material that provide low material creep and precisesize to allow consistent and predictable rates to be provided throughthe regulation of the pumping actuator 532. The rate of rotation of thepumping actuator 532 is regulated by a controller (not shown) to providea medicament product flow required by a downstream treatment such as aflow commanded by a cycler 106 and received thereby, or some otherconsuming device such as storage container.

A first concentrate is received through a first medicament concentrateline 542 and is pumped at a rate controlled by the controller to providea predefined dilution rate of the combined flow emerging from thejunction 501. The mixed diluted first concentrate flows into a firstconcentration measurement module 535A. Each concentration measurementmodule 535A-535D is described in more detail with regard to FIGS. 11Athrough 11D, infra. The mixed diluted first concentrate flows into thefirst concentration measurement module 535A and contacts conductiveelectrodes, one of which is indicated at 512. A current is driventhrough a column channel of the concentration measurement module 535 aand a voltage drop is measured across the conductive electrodes 512using the conventional four-point conductivity measurement scheme inorder to reduce contact resistance error. The fluid emerging from thecolumn channel is received in a temperature measurement cell 511 andthen flows into a second concentration measurement module 535B withtemperature measurement cell 508 and conductive electrodes 510 (only oneindicated, but the other is evident by inspection). The secondconcentration measurement module 535B provides a redundant indication ofconductivity and temperature to confirm accuracy by agreement betweenconcentration measurement module 535A and concentration measurementmodule 535B. The controller or an independent module may output a signalor data indicative of concentration based on temperature andconductivity. The signals indicating conductivity and temperature may beconverted to concentration responsively to stored (in a data store ofthe controller—not shown separately) conductivity-temperature curves forthe solution received thereby. The same is done using temperature andconductivity signals from concentration measurement module 535C andconcentration measurement module 535D as well.

The diluted first concentrate is received at a junction 509 where itcombines with a flow of second concentrate pumped through the pumpingtube segment 528 by pumping actuator 530. The second concentrate isdrawn through a second medicament concentrate line 543. The flow rate ofthe diluted first medicament is determined by the combined flow rates ofthe flows in pumping tube segments 526 and 527 which are regulated bythe controller (not shown) through control of the actuator (532, 531)speeds. In a similar manner, the flow through the pump segment 528 isregulated by the rate of the pumping actuator 530 such that theconcentration of the mixture emerging from the junction 509, whichincludes the first and second concentrates plus the dilution water, isregulated by the relative rotation rates of the three pumping actuators532, 531, and 530. In this example, the concentration of the mixtureemerging from the junction 509 represents a final concentration ofproduct medicament and it is measured using the concentrationmeasurement module 535C and then redundantly measured using theconcentration measurement module 535D. As described above, theconcentration measurement module 535C and the concentration measurementmodule 535D have conductive electrodes 506 and 505, respectively andtemperature measurement cells 507 and 504. The conductive electrodes512, 510, 506, 505 (each of the numerals identifying a pair ofconductive electrodes) make contact with fluid in a respective one ofthe conductivity measurement columns 516, 517, 518, 520 (shown in brokenlines indicating they are behind the fluid circuit 533 support 529.

The product medicament flows into a diaphragm chamber of an accumulator502 which reduces flow fluctuations by expanding and contracting withthe help of an urging element as can be seen in reference to FIGS. 12A,12B, 8H, 8J, and understood from the attending discussions. Flow entersthe accumulator 502 at a junction 525 and flows out through a pair ofpinch clamp segments 522 and 523, each leading to a respective outletline 544 and 545. The outlet line 544 is connected to a drain and theoutlet line 545 is provided with a connector for connection to aconsuming device such as cycler 106. The cartridge 500 may bepre-connected with concentrate containers 492 and 493, capped with caps495 so that the entire assembly is sealed from the environment, andsterilized before packaging for delivery and/or storage. The cartridge500 may attached to a rigid container 494 such a box such that it can beremoved from the container 494 and slid onto a shelf while positioningthe cartridge 500 in the medicament proportioning module 104, where thefirst medicament concentrate line 542 and second medicament concentrateline 543 are of sufficient length to allow them to extend between thepositioned cartridge 500 and a storage by for the container 494. Inembodiments, the container 494 can be a cardboard box or plastic box.

Referring to FIGS. 12A, 12B, and 12C an urging mechanism 581 includes aflexible cover 589, with a retaining ring 588 bolts (592) to a constantpressure mechanism 583 that has button 582 that slides within a housing580 urged by a spring 590. In an embodiment of a fluid circuit cartridge597, shown in FIG. 12C, flow enters the accumulator 591 through an entry593 and flows out of the accumulator 591 through a pair of openings 596and 599. A fluid circuit portion of the cartridge is formed from aplanar member 592, which may be formed by injection molding, with wallfeatures formed on the wall that create the various flow channels whenthey are sealed by an overlying film (not apparent in the drawing butjoining adjacent wall features to form the channels). The film may bethermally bonded, welded or glued in place as mentioned elsewhere. Theflow is guided through the fluid circuit 597 cartridge by channels 598.The internal volume of the accumulator 591 is formed in the same way asthe channels with an extra step. A film is attached to a round wall 585thereby forming one side of the accumulator chamber. The film is thenheated so that it stretched into the accumulator 591 interior volumethereby providing flexible wall of the accumulator so that it can behaveas a diaphragm or bladder.

The film forming a flexible wall of the accumulator 591 (formed by afilm as discussed below) presses against the cover 589 in turn applyinga force against the button 582 causing the spring 590 to contract. Thebutton 582 floats on an elastic (e.g., neoprene) web 567 that is held atits periphery by the ring. The button may be bonded to the elastic web567 such that it floats and requires to sliding or rolling-bearing guidethat might produce more friction. The urging mechanism 581 thusbeneficially provides very little hysteresis in the force applied duringforward and backward movement as it compensates volume changes in theaccumulator. At the same time, the restoring force of the spring andelastic web cause the button 582 to seek a central position as theyrelax. As fluid flows through the diaphragm chamber 591, any excesspressure, which is determined by the spring constant of spring 590 andthe effective area of the button 582, causes the diaphragm chamber 591to expand as the spring 590 contracts. This compensates an increase inpressure that might otherwise occur in a non-compliant channel. Thisallows the pumps of the upstream water purification module 102 andmedicament proportioning module 104 to continue running at a uniformrate even if a cycler 106 or other consuming appliance demands productmedicament fluid in a periodic or uneven fashion. The illustrated fluidcircuit cartridge 597 has features as discussed above with reference toFIG. 10 and further includes a handling tab 595 to aid insertion of thefluid circuit cartridge 597. In use, the urging mechanism 581 is pressedagainst the diaphragm chamber 591 when the fluid circuit cartridge 597is installed in the medicament proportioning module 104. In the drawingthe urging mechanism 581 is shown separated from the diaphragm chamber591 for clarity. The accumulator is formed by a circular wall that ispart of the 598

Referring to FIGS. 11A through 11D, a concentration measurement module535 as described above is now detailed according to an exampleembodiment. A section of a cartridge support 556 may correspond to aportion of 9C, cartridge 406, or the support 529 of cartridge 500described above. Thus the edges of the cartridge support 556 may beconsidered to extend and not be limited to the particular shape or sizeillustrated, the portion shown being merely a portion of a largersupport structure. An inlet flow of conductive fluid enters through aninlet channel 566 molded into the cartridge support 556. A wall 467rises from the plane of cartridge support 556 to define the channel 566.The edge of the wall 567 may be sealed with a plastic film to makechannel 566 pressure-tight. Flow, indicated by arrow 564, entering thechannel internal volume 557 from other parts of the cartridge support556 leaves the channel 566 through an opening 568 where it flows into aflow column housing 575 as indicated by arrows 574, and flows from anend opposite the entry to an opening 570 in cartridge support 556. Fromthere, the flow traverses a temperature measurement chamber 563 towardan exit channel 572 which is on an opposite side from the opening 570where the flow entered the temperature measurement chamber 563. The flowleaves the concentration measurement module 535 as indicated by arrow562. The temperature measurement chamber 563 and channel 572 may besealed in the same fashion as channel 566 such that the temperaturemeasurement chamber 563 forms a flat broad chamber. A temperaturetransducer may be placed against the face of the film that is used toclose the temperature measurement chamber 563 providing a broad contactarea for accurate temperature measurement that limits edge losses thatcan bias the temperature measurement. In addition, a zero-fluxtemperature sensor can be used which actively cancels heat flux due toconduction through the major face of the temperature measurement chamber563 finds excellent application here because of the high sensitivity ofconcentration to temperature. Bosses 552 may be provided for support andadditional structure and sealing competence in the cartridge support556.

Conductive electrodes 550, 577 may be bonded, welded, press-fitted,molded or otherwise affixed to the cartridge support 556 (a portionbeing shown at 576). In use, spring biased contacts 571 and 573 arepressed into each conductive electrode 550 while at the same time, atemperature transducer 577 is held against the temperature measurementchamber 563 as an sensor backplane 587 portion is held against theconcentration measurement module 535 as a result of the entire cartridgebeing positioned in place in medicament proportioning module 104 andengaged for use. That is, when a cartridge of any of the embodiments,carrying the concentration measurement module 535 is positioned in placein a medicament proportioning module 104 and registered, the springbiased contacts 571 and 573 and temperature transducer 577 are placedagainst the conductive electrodes 550 and temperature measurementchamber 563 so that measurements can be taken by the connectedcontroller. Note that FIGS. 11B and 11D are exploded views.

FIGS. 13A and 13B show front (FIG. 13A) and back (FIG. 13B) sides of amedicament preparation system 600 with replaceable components 640, 641,658, and 659, in FIG. 13B shown separated from medicament preparationsystem 600 and oriented for installation. The medicament preparationsystem 600 may combines water purification module 102 and medicamentproportioning module 104 that with a support for a cycler 106 (notshown) which can be positioned in a track 603. A housing of themedicament preparation system 600 is generally cubic in shape. Thereplaceable components are a cation resin bed 659 and an anion resin bed658 that together form a primary stage of a deionization filter, acarbon filter 640, and a mixed (cation/anion resin) bed 641 that forms asecondary stage of the deionization filter. Together these correspond,respectively to activated carbon filter 204, primary resin cation stage205, primary resin anion stage 206, mixed resin bed 208, which werediscussed above. A product medicament line 608 for output of productmedicament is shown with a connector 610. This may be connected to acycler 106 or other medicament consuming device that may sit on top of ahousing 601 of the medicament preparation system 600. Respective catchmechanisms 648 guide engagement caps 607, 614, 644, and 645 and fluidlyconnect and retain, the cation resin bed 659, anion resin bed 659,carbon filter 640, and mixed bed 641, respectively. The catch mechanisms648 and engagement caps are described in further detail below. Lowerreceiving support fixtures 620 receive lower ends of respective ones ofthe cation resin bed 659, anion resin bed 659, carbon filter 640, andmixed bed 641. A respective one of the latter may be installed bypositioning its lower end in a respective one of the lower receivingsupport fixtures 620 and tilting upright into a respective one of thecatch mechanisms 648 to make fluid connections and hold the respectiveone of the cation resin bed 659, anion resin bed 658, carbon filter 640,and mixed bed 641 in place.

A control and cartridge receiving module 618 has a user interface withcontrol keys and a display 651. A receiving slot 606 receives acartridge 611 which may conform to any of the cartridges 406, 450, or500, and other of similar description. Actuators and sensors (not shownhere) within the receiving slot 606 engage the pumping and valve tubesand sensors as well as electrical contacts of the foregoing cartridgeembodiments, particularly cartridge 500. Ultrafilter module 616, whichmay correspond to sterile filter stage 210, may be loaded from themedicament preparation system 600 front side. The medicament concentratedisposable package 617 may also be loaded from the medicamentpreparation system 600 front side and may correspond to the container orbox 484 housing the fluid circuit 470A, 470B, or 470C. The cartridge mayhave additional lines including a pure water inlet 613 to carry purifiedwater into the cartridge 611 and a drain line 615 to carry divertedmedicament to a waste outlet via internal plumbing in the housing 601that also routes water to a waste outlet from the medicament preparationsystem 600 (not shown). Tap water may be provided to the waterpurification module 102 via tap water line 612 also connected at thefront of the housing 601. Medicament concentrate lines 619 may flowmedicament from the medicament concentrate disposable package 617 to thecartridge 611 for proportioning with the purified water that is conveyedfrom the water purification module 102 through the pure water inlet line613. Connectors 610 provide connections to the various ports for theidentified fluid lines. An additional water-in line that creates asaturated concentrate from powdered solute in embodiments of medicamentconcentrate disposable package 617 may be provided in variations of themedicament preparation system 600 as shown in FIG. 13C, discussed below.

FIGS. 13C, 13D, and 13E show connection schemes according to thedisclosed embodiments. A medicament preparation system 600 which issimilar to those discussed elsewhere uses replaceable components 640,641, 658, and 659, as in FIG. 13A and as described elsewhere. Aninterconnection scheme is illustrated for allowing the attachment of thewater purification components of a water purification module 102 housedin the housing 601 of the medicament preparation system 600 to tap water(received through tap water line 612) and drains some water as explainedabove (through drain line 615), as well as connecting a product wateroutput to a medicament proportioning module 104 whose fluid circuits areentirely disposable. The medicament concentrate disposable package 617is connected to the cartridge 611 to receive concentrate through lines619. A medical treatment device such as a cycler receives productmedicament from the cartridge through a product medicament line 608connected to the cartridge 611. The cartridge receives pure waterthrough pure water inlet line 613. In the case where dry buffer isprovided in the medicament concentrate disposable package 617 ratherthan a liquid concentrate buffer or a mixed concentrate with acid andbuffer already mixed (e.g., lactate or acetate buffer), pure waterreceived by the dry medicament cartridge 611A in disposable package 617through a pure water bridge line 629 which is connected to the purewater inlet line 613 and controlled by an actuator in the receiving slot606 for the cartridge 611. Product medicament 639 and waste 637 may exitfrom the cartridge 611B, the former being connected to a drain and thelatter to a consuming device.

As in system 600, the medicament preparation system 600A may combinewater purification module 102 and medicament proportioning module 104that with a support for a cycler 106 which can be positioned in a track603. As in the earlier embodiments, the replaceable components are acation resin bed 659 and an anion resin bed 658 that together form aprimary stage of a deionization filter, a carbon filter 640, and a mixed(cation/anion resin) bed 641 that forms a secondary stage of thedeionization filter. Together these correspond, respectively toactivated carbon filter 204, primary resin cation stage 205, primaryresin anion stage 206, mixed resin bed 208, which were discussed above.An output line for product medicament 608 is shown with a connector 610,as in the embodiment of FIG. 13A, and may be connected to a cycler 106or other medicament consuming device that may sit on top of a housing601 of the medicament preparation system 600A. Connection mechanisms areas described above for the cation resin bed 659, anion resin bed 659,carbon filter 640, and mixed bed 641, respectively as are the supportfixtures.

The control and cartridge receiving module 618 has a user interface withcontrol keys and a display 651. In the embodiment of FIG. 13C, thereceiving slot 606 may receive a cartridge 611A adapted for interfacingwith a fluid circuit that uses a bicarbonate cartridge (contained in themedicament concentrate disposable package 617A) as described withreference to FIG. 8B, 15B (infra) and elsewhere. Actuators and sensorswithin the receiving slot 606 engage the pumping and valve tubes andsensors as well as electrical contacts of the cartridge 611A.Ultrafilter module 616 and medicament concentrate disposable package617A (similar to medicament concentrate disposable package 617) are asdiscussed elsewhere.

A tap water line 612 conveys water from a tap to the water purificationmodule (which may be as in any of the disclosed embodiments consistentwith the present description). Pure water inlet line 613 directs pureproduct water from the cartridge to the medicament concentratedisposable package 617 for use in creating a saturated bicarbonatesolution using the bicarbonate cartridge as discussed elsewhere. Themedicament preparation system 600A may also have a drain line 637leading from the cartridge 611A to a drain (See for example waste line422 outlet line 544 outline line 545 and other similar examples ofcartridges that may be employed in the present embodiment). Medicamentconcentrate lines 619 bring medicament concentrate from the medicamentconcentrate disposable package 617 to the cartridge 611A forproportioning with the purified water carried through line 613.Connectors 610 provide connections to the various ports for theidentified fluid lines. An additional pure water line 629A conveys someof the pure water conveyed through 613 that creates a saturatedconcentrate from powdered solute in embodiments of medicamentconcentrate disposable package 617 may be provided in variations of themedicament preparation system 600A. The embodiment 600A shownschematically in FIG. 13D uses a medicament concentrate disposablepackage 617 that contains a dry buffer cartridge and therefore receivespure water through additional pure water line 629. The embodiment 600Bshown schematically in FIG. 13E uses a liquid medicament concentratebuffer in medicament concentrate disposable package 617 and thereforedoes not have an additional pure water line 629 for the cartridge 611B.

FIGS. 14A and 14B illustrate disposable filter cartridge connection andother mechanical features of a water purification module 700 module ofthe medicament preparation system 600, according to embodiments of thedisclosed subject matter. Guide engagement caps 607 and 614 form a firstpart of the catch mechanisms 648 mentioned above which secure the cationresin bed 659, anion resin bed 658, carbon filter 640, and mixed bed 641in place and make the fluid connections therefore. That is, each of themodules for the cation resin bed 659, anion resin bed 658, carbon filter640, and mixed bed 641 has a respective guide engagement cap 614, 607,645 and 644. Each engagement cap has alignment portions 715 shown FIG.14B that have straight side tabs 717 the fit into slots 647 of a bracket649 of each catch mechanism 648. The bracket is shown separately in FIG.14C. The straight side tabs 717 are aligned in the vertical directionwith the slots 647 when each of the cation resin bed 659, anion resinbed 658, carbon filter 640, and mixed bed 641 is placed in a respectivelower receiving support fixture 620. In order to slide into each slot647, the respective guide engagement cap 614, 607, 644, 645 has to beoriented with its edge 717 parallel to the slot 647. This forces thefluid couplings 702, 707 of anion resin bed 658 and fluid couplings 711,712 of cation resin bed 659 to align respectively with receivingcouplings 702, 703, 709, 710 of the medicament preparation system 600.The receiving couplings 702, 703, 709, 710 may be provided with a springdevice that pushes the fluid couplings 702, 707 of anion resin bed 658and fluid couplings 711, 712 of cation resin bed 659 away so as to forcethe installer to push against this force until a latch 720 on each catchmechanism 648 engages and retains the respective alignment portion 715,716. In this way fluid lines 704 are connected with respective portionsof the medicament preparation system 600. The above details of catchmechanism 648 of anion resin bed 658 and cation resin bed 659 weredescribed, however the same details may apply to those of carbon filter640 and mixed bed 641 and associated fluid couplings and receivingcouplings. FIG. 14D shows the latch 720 in a raised position where itmay be held by a user during the positioning of a respective guideengagement cap 614, 607, 645 and 644. When released, the latch 720 isurged into a retaining position as indicated in FIG. 14B and others.Although the with its edges 715, 717 for example (and similar elements)and the bracket 648, 649 slots 647 are illustrated as straight, toreduce tolerance one or both may be curved at radii corresponding to aradius whose center is near the lower receiving support fixture 620 toreduce the tolerance required. Alternatively one or both may beveled tocause a low tolerance fit near the final position of engagement.

Referring now to FIG. 15A, a cartridge 770 may provide the fluid circuitelements described with reference to any of the above cartridgeembodiments including concentration sensor stations, accumulator, valveclamping tube segments, and pumping tube segments which are oriented andpositioned by mounting the cartridge. The cartridge 770 may also have adata carrier as described that provides data concerning characteristicsof the cartridge and all the fluid circuit elements of the fluid circuit748 indicated by reference-numeral 748, including the composition ofmedicament concentrates contained in attached containers 750 and 752. Aninlet line 762 has an inline sterile filter 756 and a primary inlet 754connectable to a source of pure water which is capped and sealed. Afirst medicament concentrate line 763 and a second medicamentconcentrate line 764 are connected to allow concentrate to be pumpedinto a medicament supply line in a predefined proportion with waterpumped through inlet line 762. Kink-type clamps, which are described in,for example, International Publication No. WO 2007/118235 (see, forexample, FIGS. 30A through 32 of said publication) seal the firstmedicament concentrate line 763 and the second medicament concentrateline 764, respectively. Waste line 769 and product medicament line 768lead out from a common medicament supply line and capped and sealed asindicated at 754. Concentrate feed inlets 759 and 760 are provided tofill the concentrate containers 750 and 752, respectively, throughsterile filters 756. The entire fluid circuit may be sealed, includingthe kink-type clamps 772, and respective medicament supplies may beconnected to connectors 758. Medicament concentrate may be pumped intothe concentrate feed inlets 759 and 760 until a predefined quantity issupplied, then the concentrate feed inlets 759 and 760 can be welded toseal them at a point therealong as indicated at 761. The welding cansimultaneously cut off the filter 756 and 758. Then the entire fluidcircuit 748 may be sterilized. In alternative embodiments, the fluidcircuit 748 is sterilized before medicament concentrate is pumped in,the sterile filters 756 ensuring no contamination enters the sealedfluid circuit 748. If the fluid circuit is sterilized after filling withmedicament concentrate, the sterile filters 756 on the concentrate feedinlets 759 and 760 may be omitted. In any of the embodiments, instead ofwelding a line to seal it, a non-reopenable clamp may be applied to theline to seal it. In other alternatives, other types of sealing may beemployed. In any embodiments where a kink-type clamp is used (e.g. 772)a frangible valve may be used instead.

Note in any of the embodiments described herein, other types of tubingclosures may be used. For example, frangible-seal valve-type closuresmay be used. An example of a frangible-seal valve is described in U.S.Pat. No. 4,586,928. The medicament proportioning module 104 may beequipped with an actuator to open a frangible-seal valve automaticallyduring a set-up procedure. In a method, after installing the fluidcartridge, a linear actuator aligned with a frangible-seal valve by thepositioning of the cartridge, may be controlled to open the valve inresponse to a command from a controller. The command may follow thecomplete preparation for a treatment, for example and a user input to auser interface indicating that the system should begin priming inpreparation for treatment.

FIG. 16A is a flow chart of a process for making the fluid circuit 748.At S50, the fluid circuit 748 is assembled by permanently welding orotherwise bonding the elements of the fluid circuit 748 together. Thefluid circuit 748 may be sterilized at S52. Medicament concentrate maybe pumped into the concentrate feed inlets 759 and 760 until apredefined quantity is supplied at S54. The concentrate feed inlets 759and 760 can be welded to seal them a point therealong as indicated at761 at S56. The complete fluid circuit with concentrate may then bepackaged in a box or other container with the cartridge 770 eitherattached or stored within the box or other container S58.

Referring now to FIG. 15B, a cartridge 770 may provide the fluid circuitelements described with reference to any of the above cartridgeembodiments including concentration sensor stations, accumulator, valveclamping tube segments, and pumping tube segments which are oriented andpositioned by mounting the cartridge. The cartridge 770 may also have adata carrier as described that provides data concerning characteristicsof the cartridge and all the fluid circuit elements of the fluid circuit749 indicated by reference-numeral 749, including the composition ofmedicament concentrates or dry medicament solute contained in theattached container 752 and cartridge 778 of a type that receives waterat an inlet 480 and produces a saturated solution from dry solute storedin the cartridge. An inlet line 762 has an inline sterile filter 756 anda primary inlet 754 connectable to a source of pure water which iscapped and sealed. A first medicament concentrate line 763 and a secondmedicament concentrate line 764 are connected to allow concentrate to bepumped into a medicament supply line in a predefined proportion withwater pumped through inlet line 762. Kink-type clamps, which aredescribed in, for example, International Publication No. WO 2007/118235(see, for example, FIGS. 30A through 32 of said publication) seal thesecond medicament concentrate line 764. A junction 776 connects thewater inlet 762 to water inlet line branches 767 and 773. The branch 773leads to inlet of the cartridge 778 through a connector 774. Waste line769 and product medicament line 768 lead out from a common medicamentsupply line and are capped and sealed as indicated at 754. Concentratefeed inlet 760 is provided to fill the concentrate container 752 throughsterile filters 756. The entire fluid circuit may be sealed, includingthe kink-type clamp 772, and respective medicament supplies may beconnected to connectors 758. Medicament concentrate may be pumped intothe concentrate feed inlets 759 and 760 until a predefined quantity issupplied, then the concentrate feed inlets 759 and 760 can be welded toseal them a point therealong as indicated at 761. The welding cansimultaneously cut off the filter 756 and 758. Then the entire fluidcircuit 749 may be sterilized. In alternative embodiments, the fluidcircuit 749 is sterilized before medicament concentrate is pumped in,the sterile filters 756 ensuring no contamination enters the sealedfluid circuit 749. If the fluid circuit is sterilized after filling withmedicament concentrate, the sterile filters 756 on the concentrate feedinlets 760 may be omitted.

Note in any of the embodiments, a single sterilizing filter may be usedto fill the concentrate containers of multiple fluid circuits likesealed fluid circuit 749. This may be done by connecting multiple fluidcircuits to a single filter with a manifold. The latter may besterilized prior to use. The fluid circuits connected to the filter andmanifold may be sterilized after connection to prevent touchcontamination from making the connection or the connection may be donein a sterile environment. The circuits may be filled and then sealed as761, discussed above.

FIG. 16B is a flow chart of a process for making the fluid circuit 749.At S66, the fluid circuit 749 is assembled by permanently welding orotherwise bonding the elements of the fluid circuit 749 together. Thebuffer cartridge 778 may be connected to the water inlet branch 773 S68.The fluid circuit 749 may be sterilized at S70. Medicament concentratemay be pumped into the concentrate feed inlet 760 until a predefinedquantity is supplied at S72. The concentrate feed inlet 760 can bewelded to seal it a point therealong as indicated at 761 at S74. Thecomplete fluid circuit 749 with concentrate may then be packaged in abox or other container with the cartridge 770 either attached or storedwithin the box or other container S76.

FIG. 17 shows a portion of a fluid circuit cartridge 800 to illustratehow electrical, thermal, and mechanical engagement of actuators andsensors are provided using the fluid circuit cartridge device. A fluidcircuit base planar element 812, for example, injection molded plastichas molded walls that define channels 826 having a generally uniformcross section and may be covered by film by welding or adhesive. Thewall extend from a base portion of the planar element forming a troughand the edges of the walls remote from the base element are then sealedwith the film, fully closing the trough to form the channel. The filmmay be thin to minimize thermal resistance between a temperature sensor815 (supported on a support 814) and the fluid carried by the channel826. A channel 826 portion for engagement with temperature sensor 815may be flattened out to reduce edge flux effects on the temperaturemeasurement. In general, the channels 826 may be straight or curvedsegments that convey fluid with minimal resistance. Openings such asindicated at 804 allow the flow in the channels 826 to flow (see arrows813) into other features such as a column channel 802 for measuringconductivity using electrodes 808 and the accumulator (not shown). Theelectrodes make electrical contact with contact pins 806 (which may befour in number for measuring contact resistance and for four-pointmeasurement to minimize the effect of contact resistance on theconductance signal) also supported on an opposing planar actuatorsupport indicated by dot-dash line 814 but which may be any type ofsupport or supports. The temperature sensor 815 and contact pins 806 maybe backed by urging elements such as springs. Pumping tube segments 820can be clamped between a roller actuator 822 and a race 824,respectively supported on support 814 and an opposing support 829. Apinch clamp segment 832 of tubing can be positioned between clampingelements 830 supported on support 814 and clamped by a pinch clamptubing segment. All of the engagements required are convenientlyprovided by moving the supports 814 and 929 in opposing directions asindicated by arrows 816 around the fluid circuit base planar element812. Further, some of the fluid carrying features are formed by thefluid circuit base planar element 812 including the channels.Connections to the tube segments can be formed in the channel by moldingas well. A tubing segment with a valve 845 such as a frangible-sealvalve may be positioned to be opened at a time of set up and priming byan actuator motor 843 and actuator 844. Here the fluid circuit baseplanar element 812 may serve as a backstop to resist the force appliedto the valve 845 or the actuator 844 may provide a clamping or scissoraction that does not require an opposing support. Windows

Another fluid circuit feature that can be formed in the fluid circuitbase planar element 812 is a pressure sensor region 847, which may beformed similarly to the temperature channels 826. The overlying filmprovides a compliant surface that can apply force to a strain gauge 848pressed into engagement with the overlying film of the pressure sensorregion 847 when the 816 are positioned to engage the fluid circuitcartridge 800 elements. Openings 804 and elbows 849 (See example 863 inFIG. 18A of elbow that communicates with a concentrate pumping tubesegment 864 shown in FIG. 18A and discussed relative thereto) may alsobe made in the fluid circuit base planar element 812 with to flow fluidfrom channels 826 to tubular portions such as a pinch clamp tubingsegment 832, a valve 845, or pumping tube segment 820 attached at theopposite side of the fluid circuit base planar element 812.

As discussed above, the fluid circuit base planar element 812 may alsosupport a data carrier 833 that is positioned when the cartridge isinstalled, to be read by a reader 831.

In embodiments, the fluid circuit base planar element 812 may be moldedsuch that all the all the side action mold parts can be drawn in thesame direction. As may be verified by inspection of elbows 863 on FIG.18A (same features unlabeled in FIG. 18B), may be molded in the samedirections as column channel 802 using a single side action in themolding process. This is disclosed clearly in FIG. 18A and discussed inconnection with flow column housing element 891 which is formed as anopen ended element with a sealing member 894 to close it after molding.

In embodiments, the fluid circuit cartridge 800 may position all thesensor and actuator surfaces on one side of the fluid circuit baseplanar element 812. This allows all the actuators and sensors and theirassociated wiring and circuitry to be positioned on a first side andsupported by only the support 814. The opposing support 829 can bepassive. In the example shown, the opposing support 829 supports onlythe race 824 (a member often called a “shoe”). To facilitate tightpacking of the elements, some of the larger elements such as columnchannel 802, pinch clamp tubing segment 832, a valve 845, and pumpingtube segment 820 can be attached on the opposite side. This allows thesensors and actuators to be larger than they would be able to be ifthese elements were on the other side. Rather, most of the first side isflat or open. This can allow the cartridge to be much smaller thanotherwise possible.

FIGS. 18A and 18B show details of fluid circuit cartridges according toembodiments of the disclosed subject matter. The fluid circuit cartridge850A is optimized for use with a dry medicament cartridge in medicamentconcentrate disposable package 617 and fluid circuit cartridge 850B isoptimized for use with liquid concentrates in medicament concentratedisposable package 617. A cartridge structural element 853 has acartridge support element top edge 852, a cartridge support elementlower edge 854 and a cartridge support element grip edge 851. A supportstrut 873 may be provided to stiffen a fluid circuit planar element 861.The cartridge support element top edge 852, cartridge support elementgrip edge 851, and cartridge support element lower edge 854 may be onepiece attached to the fluid circuit planar element 861, or separateelements that are interattached through the fluid circuit planar element861. The cartridge support element grip edge 851 segment of cartridgestructural element 853 has an extended portion that facilitatesinsertion and removal of the fluid circuit cartridge 850A and 85B. Fluidcircuit planar element 861 may correspond to, for example, fluid circuitplanar element fluid circuit base planar element 812. An accumulator, asdiscussed in other embodiments, is located in the region 860 behind theviewpoint of FIG. 18A. Fluid channels (see reference-numeral 826 andattending discussion) as described above are formed in fluid circuitplanar element 861 to interconnect the various elements of the fluidcircuit cartridge 850A. As described elsewhere in the presentapplication, fluid circuit cartridges such as fluid circuit cartridge850A may have conductivity sensors with column channels, temperaturemeasurement cells, pinch clamp segments, valve such as frangible-sealvalves, pumping tube segments, electrodes, data carriers, etc. The fluidconveying elements may be interconnected by fluid channels as describedwith reference to reference-numeral 826.

Two concentrate pumping tube segments 866 and 864 draw concentratethrough a first medicament concentrate line 878 and a second medicamentconcentrate line 878. The first pumping tube segment 866 and secondmedicament concentrate line 864 communicate with channels formed influid circuit planar element 861 (on the other side of fluid circuitplanar element 861 but see FIG. 17 for description) via elbows 863molded into the fluid circuit planar element 861. A frangible-seal valve867 is openable by an actuator as discussed with reference to FIG. 17 toallow the medicament concentrate from a connected container to flowthrough it. See FIGS. 15A and 15B for discussion of connected medicamentconcentrate containers or dry solute cartridges. Fluid circuit cartridge850B has two frangible-seal valves 867, one each for two medicamentconcentrate lines 878 and 875. Fluid circuit cartridge 850A may not needa frangible-seal valve 867 for the dry medicament cartridge used in themedicament concentrate disposable package 617 where dry bicarbonatepowder or other dry solute is used instead of a liquid concentrate. In amethod, the cartridge 850A or 850B is inserted in a receiving slot (e.g.606 of FIG. 13C) and prior to the generation of product medicamentduring a setup procedure, the frangible-seal valve 867 seal is broken sothat liquid medicament concentrate thereafter can be pumped. This may bedone in preparation for, or to fully complete, a priming operation.Windows 855 in the cartridge structural element 853 provide access tothe frangible-seal valve 867 for actuators in the receiving slot (e.g.606) to open the frangible-seal valves 867 as well as to a pinch valvesegment 865 presently discussed.

An additional pure water line 872, which has the function described ofpure water line 629 of FIG. 13E, sends pure water, under control of apinch valve segment 865. The pure water is drawn through a junction 879connected to the pure water inlet line 871 from the water purificationmodule 102. The pinch valve segment 865 may be controlled by a valvepinching actuator in the receiving slot (e.g., receiving slot 606). Byproviding the additional pure water line 872 in the cartridge 850A, thevalve pinching actuator for controlling the flow in additional purewater line 872 can be conveniently positioned with respect to the pinchvalve segment 865. The additional pure water line 872 has an inlinesterilizing filter 869 that guards against the entry of desterilizingcontaminants into the product medicament. Pumping of the pure water isaccomplished by an actuator in engagement with pumping segment 862.Product medicament passes into the accumulator which opens to pinchvalve segments 858 and 859 which pass product (or waste, depending on astate of the medicament proportioning module 104, through productmedicament line 876 or waste line 874.

The drawings of the fluid circuit cartridge 800A, 800B and fluid circuitplanar element 861 illustrate another feature that may be provided. Theconcentration measuring stations include flow column housing elements891. In an alternative embodiment, which is illustrated, most of thebody of each flow column housing element 891 is integrally formed withthe fluid circuit planar element 861, with one closed end, using a sideaction molding part. The open end 893 is closed by a sealing member 894after the formation of the fluid circuit planar element 861. This may bedone to form all the flow column housing elements 891 (only one of whichis labeled, but there may be four, as illustrated, and as discussed inforegoing embodiments). The features such as 863 may be formed using thesame side action mold and these parts may be ganged to provide a singlemolding operation.

FIG. 19 shows schematically and figuratively a combined waterpurification, medicament proportioning and treatment system to highlighta feature by which leakage current is minimized, according toembodiments of the disclosed subject matter. A medicament supply andtreatment system 900A is illustrated figuratively at 900A andschematically as an electrical circuit transferring leakage current to apatient at 900B. The medicament supply and treatment system 900Asupports a blood treatment systems susceptible to leakage current fromelectric heater used to heat medicament due to the inherent formation ofa conductive fluid path between the current sources and the patient 918.In FIG. 19, the sources are indicated collectively by the symbol 901.Many of the sources of leakage current can be capacitive and inductivesources that can generate a current in a fluid line carrying fluid oflimited conductivity, such as a medicament line. An electrical heater903 can be a particularly strong source of leakage current. Inembodiments, the electric heater 903 is a variable heater under feedbackcontrol of a controller to maintain a target temperature. Inembodiments, the target temperature is based on the patient propertiesor measurements. The temperature of fluid in thermal contact with theblood of a patient can affect the raising or lowering of the bodytemperature of the patient 918. In dialysis, for example, the dialysatehas a high concentration of electrolytes that is pumped, by a pump 923,and circulated in direct contact (wetting contact) across the pores ofthe membrane of a blood treatment component 920 (in this case adialyzer), with the blood of the patient circulating in a blood circuit917 under the urging of a blood pump 915. Thermal contact, as well asthe electrical continuity poses the problem of leakage current transferto the patient. Note the blood treatment component 920 may be adialyzer, hemofilter, hemodiafilter, liver dialysis filter, or thepatient's peritoneal membrane as in peritoneal dialysis or other devicesthat cause the electrical circuit to exist. Thus, in extracorporealblood treatments, the medicament is pumped through a device thatexchanges both heat and electric current with the patient's blood.

A water purification module 902 may have a pump 925 and a controller(not shown). The water purification module 902 may have deionizationfilters of sufficient capacity and the pump may be controlled such thatthe water is purified to a level of purity exceeding a predefinedresistivity. A predefined resistivity may be, for example, 1 megohm-cm.In an example embodiment, the predefined rate is 2 megohm-cms. Infurther examples it is 3 megohm-cms, 5 megohm-cms or up to 10megohm-cms. Various parameters, depending on the type of waterpurification system can provide resistivity levels as high as thepredefined resistivity. For example, reverse osmosis can be used forachieving such high resistivity although deionization resin beds may bemore practical for such levels of purity. Here the drawing illustratesmultiple stages of filters 906 used for water purification and these maybe as described elsewhere herein in connection with water purificationmodules or other types of water purification systems. The purified waterwith the predefined resistivity or higher passes through a heater 903.Note in embodiments, the heating may occur at an earlier stage such thatthe resistivity of the water is not as high as the predefinedresistivity or higher. A feature of the present embodiment is that thereexists a high resistivity water stream 912 (exceeding the predefinedresistivity) between the heater 906 and other current sources 901 andthe remainder of the fluid circuit including a low resistivitymedicament path 916 and a low resistivity blood circuit path 916. Thus,to provide heat, the system 900A interposes a high resistivity fluidpath between current sources including the heater 903 and the patient918. The heater 903 is regulated to control the temperature of thepatient. This may be done by controlling the temperature of themedicament circulating in the blood treatment component 920.

In embodiments of the above system, medicament concentrate is added tothe water of a predefined resistivity to make the medicament that isultimately used for treatment. Medicament concentrate 914 is injected inthe high resistivity water forming medicament and flows through amedicament channel 922. The medicament then flows through the bloodtreatment component 920 forming an electrical circuit with the patientas discussed. Medicament concentrate addition may be of any suitableform including as described with reference to the embodiments disclosedherein.

A beneficial feature of the system 900A may be for the fluid channels tobe of electrically insulating material such as polyvinyl chloride orsilicone to ensure the high resistivity fluid channel is not underminedby conduction through the channel materials. The high resistivity waterchannel 924 length and cross-sectional area (local and varying over thelength thereof or constant) may be selected to ensure a predefinedleakage current target is met. The electric heater 903 may be of a typethat places the product water in direct contact with permanentnon-disposable surfaces of a flow channel in the electric heater 903.The electric heater may contain double-insulated rod-type heaters orother devices for minimizing the level or risk of undesired electriccurrent in the fluid being heated. The flow channel in the heater may beelectrically insulated. A sterile filter 906 may be placed in theinterconnection between the heater and the medicament proportioningmodule 902. The sterile filter 906 may be multiple stages. In the aboveembodiments, the use of a sterile filter at the outlet of the waterpurification module 102 ensures that sterile water flows from the waterpurification module 102 and the risk of touch contamination caused byinterconnecting the disposable fluid circuit for the medicamentproportioning module 104 is eliminated by permanently affixing a sterilefilter in the inlet of the disposable fluid circuit.

A controller for the heater 903 may be adapted for controlling theelectric heater 903 responsively to a measured temperature and/or atemperature target selected for maintaining the body temperature of thehuman patient 918. The controller of the electric heater 903 maycompensate for a heat load caused by the addition of medicamentconcentrate to the flow of product purified water. This heat load arisesif the medicament concentrate is a lower temperature than the targettemperature for the medicament used in treatment.

A length of the water channel and a resistivity of the product water maybe sufficient to ensure that said electric heater produces less than 50microamperes of leakage current through said continuous fluid path tosaid patient access. As a result, heat required to maintain bodytemperature of a patient being treated by the blood treatment benefitsfrom an electrically insulating convective flow of pure water used forthe generation of medicament used in the treatment.

FIG. 20A shows a medicament proportioning system 950A that provides amedicament mixture using a sterile circuit 952 that can be used forpreparing medicament for multiple treatments by a treatment device 954.The sterility of the sterile circuit 952 permits the sterile circuit 952to be used multiple times (at least two, for example) spaced apart by aperiod of hours or days without the risk of a growth of bacteria withinthe sterile circuit causing a risk to a patient being treated bytreatment device 954. To provide the function, the sterile circuit 952must be sterile before use and remain sterile during and betweentreatments. The function of the sterile circuit 952 includestransferring fluids, and may include mixing fluid components, as well astaking property measurements, providing pumping and flow rate controland other functions as required. The treatment device 954 is one thatmay require a sterile medicament. According to embodiments, mechanismsfor ensuring sterility may include a sterilization process or theprovision of a replacement sterile circuit 952 that has been previouslysterilized, such as a disposable fluid circuit as described withreference to various embodiments described herein. In embodiments, thesterile circuit 952 may be subjected to a sterilization process to makeit initially sterile and then some sterility mechanism 956 ensures thatthe sterility helps to maintain the sterile condition of the sterilecircuit 956 while providing enough fluid (one or more fluids 958) formultiple treatments. The sterility mechanism 956 may be embodied inseveral ways, as exemplified by the further embodiments shown in FIGS.20B to 20D. Note, the embodiments of FIGS. 20B, 20C, and 20D areexamples of the embodiment of FIG. 20A.

Referring to FIG. 20B, an example of a sterility mechanism is a sterilebarrier 970. The sterile barrier 970 includes a fluid impermeable fluidcircuit and one or more sterile filters through which all fluidsrequired for the multiple treatments is/are passed. One or more of thefluids 958 may be transferred in real time during consumption into thesterile circuit 952, or transferred and stored at some time prior totreatment and thereafter consumed. The sterile barrier 970 may becombined with other sterility mechanism 956 embodiments, for example asterile component 980 as in FIG. 20C where the sterile component 980 isa fluid which has been sterilized by some means and fluidly connected tothe sterile circuit 952 such that an impermeable barrier (e.g., fluidchannel) connects it to the sterile circuit 952. Sterile component 980may be permanently connected to the sterile circuit 952 such thatintrusion of contaminants is prevented. FIG. 20C shows a medicamentpreparation system 950C with a sterile barrier 970 that is used inconjunction with a sterile component 980 and conforms to the exampleembodiments in which pure water 908 (which may include other fluids) issupplied with a sterile barrier 970 in place, the sterile barrier mayinclude flowing water and other fluid through a sterilizing filter.Another sterile component 980 is provided as part of the sterile circuit932 and may be pre-sterilized medicament concentrate, for example, asdescribed in embodiments herein. The sterile component 980 may bepre-attached to the sterile circuit 932 by fluid lines as in embodimentsdescribed herein or may be held in a capsule of a cassette or connectedin any suitable manner so as to be subject to the sterile guarantee ofthe sterile barrier 970. FIG. 20D shows an embodiment of a medicamentpreparation system 950D in which all the sterile components 982, 980 arepre-connected to the sterile circuit 953.

Referring now to FIG. 21, an air break 107 ensures safe connection to awater mains supply and provides the protection of a backflow preventerwhile avoiding the disadvantageous requirement of inspection andtesting. The air break 107 may be included at an inlet of any of thewater purification module 102 or medicament preparation systemembodiments disclosed above and variants suggested by the presentdisclosure. See also, for example, FIGS. 1, 2, 4, 8A, 8B, and 22. Notethat the air break 107 may be placed at any point in the water systemeffective to protect against undesirable backflow into the system or asrequired by local or national plumbing codes or other legal orregulatory requirements. In an example embodiment, the air break isplaced in the tap water inlet line of a water purification module 102and downstream of features such as inlet shutoff valve, pressureregulator, inlet pressure sensor, a sediment filter. Other componentsmay be included upstream or downstream of the air break 107.

A water inlet 671 may receive water 668 delivered by mains pressureunder control of a control valve 665 which may be controlled by acontroller 690. The controller 690 may be independent, dedicated tocontrol of a water purification module 102 or one that controls anintegrated medicament preparation system or integrated treatment system.The controller may receive level signals from water level indicators660, 661, 662. Although high 660, middle 661, and low 662 levelindicators are shown, other numbers of level indicators may be provided.The controller maintains the level of water 667 within a predefinedrange (i.e., within deadband=control goal achieved) or such that apredefined level 667 is continuously pursued (i.e., specific levelestimate=control goal achieved). The level indicators 660, 661, 662 maybe optical, wet-detection sensors, floats, or any other type of leveldetector. In embodiments, the controller prevents the starvation of flowthrough an outlet 663, as demanded by a pump 691 which may be part of awater purification module 102 or a medicament preparation system or anyother system. That is the controller maintains a level 667 sufficient toallow water to be demanded as required through the outlet 663 bypermitting water through the control valve 665 until a level 667 belowan overflow outlet 669, is reached. If a reverse pressure arises,pressure in the internal volume 693 cannot rise due to the free flowthrough the overflow outlet 669.

To permit the level 667 of water in internal volume 693 to rise, air canbe vented through an air vent line 697 which may have a check valve 689to permit flow only out from the internal volume 693. The pressure inthe internal volume may be detected by a pressure sensor 699 and if apositive pressure arises, for example due to an abnormal condition suchas a blockage of the air vent line 697 and/or the overflow outlet 669,the controller 690 may output an error or prevent the operation of apump 691 demanding water. A resistivity sensor 678 may be provided todetect abnormal water resistivity and the controller 690 may output anerror indication signal in response, for example a warning on a userinterface and/or a command signal to terminate the use of the waterwhich may cause one or more pumps to stop operating and an errorindication to be displayed or otherwise output. A wetness detector 692may be placed under the air break 107 within a housing 695 to output anindication of water leak or overflow through overflow outlet 669. Thewetness detector may also apply an output signal to the controller 690to cause the latter to output an error indication and to take the stepsof preventing further operation until the fault is cleared.

FIG. 22 illustrates the advantages of the air break 107 in systemembodiments such as described in connection with principal embodiments.Tap water enters a water inlet 680 which flows into the air break 107,which may include all the features described with reference to FIG. 21and any others identified herein such that the air break level 667 ismaintained and error conditions are detected. A pump 678 of a waterpurification module 102 draws water from the air break as required tosupply a medicament proportioning module 104 which is able to, by virtueof the support of on-demand draw capability of the air break 107,control pumps 677 and one or more pump(s) 676 for medicament concentrate672 for accurate mixing. Further, the pressure of the fluid may beconsistent and unaffected by pressure variations from the mains supply668. That is, the air break 107 prevents the transmission of pressurefluctuations downstream from the outlet 663 from, for example, the mainssupply 668. For example, pumps 677 and one or more pump(s) 676 formedicament concentrate 672 may provide the most accurate mixing whenthey are operated at a constant or slowly varying rate and with aconstant inlet pressure. Fluids are combined in a junction 675. Thecycler 106 also may draw fluid at time-varying rates using a respectivepumping device 673, such as a flow balancing mechanism, to providemedicament to a treatment component 679 using the flow-rate matchingcapability of the accumulator 685 as described with respect toembodiments thereof.

In variations of the embodiment of FIG. 13A, 13B, the anion resin bed658, cation resin bed 659, carbon filter 640, and mixed bed 641 may beseparated so that they reside at the corners of the housing 601 with thecartridge receiving module 618, medicament concentrate disposablepackage 617, and medicament module 161 in the central volume betweenthem. Other variations are also possible and the disclosed subjectmatter is not limited to these particular arrangements.

Referring now to FIG. 23A, as in the fluid circuit 533, conductivity maybe measured using a series concentration measurement modules that areconnected in series or series/parallel as described with reference toFIG. 10. In the present embodiment, which may be substituted into any ofthe foregoing or following embodiments, conductivity is measured basedon multiple paths as well as the fluid column in a respectivemeasurement column, such as columns 992. A fluid flows through columns992 which are joined by channel elements 995. Additional channelelements may be included such as to inject concentrates or diluents asdescribed with reference to FIG. 10. In the latter embodiment, theresistance of fluid to the flow of current was obtained betweenconductive electrodes at either end of a respective measurement column.In embodiments, additional measurements using the same conductiveelectrodes may be made. In FIG. 23A, conductive electrodes 991 arelabeled A through H. Contact resistance on the dry side of eachelectrode may be made between current contacts and voltage sensecontacts which are provided and used according to the well-knownfour-point resistance measurement technique. In the present embodiment,resistance is measured between multiple pairs that share a givenconductive electrode 991. Not all the conductive electrodes areindicated by a reference numeral to avoid clutter but each is labeledwith a respective letter. Here, conductive electrode pair A-B is usedfor a resistance measurement through a respective fluid column 992.Further, conductive electrode pairs A-D and A-C are also used for aresistance measurement through a respective fluid column 992 pluschannel element 993 and a respective fluid column 992 plus channelelement 993 plus fluid column 992, which form respective longer fluidpaths. The same may be done with conductive electrode pairs B-C, B-D,and C-D. Given known properties of the respective channels, which may bestored explicitly or tacitly (e.g., by way of a formula or look uptable), the fluid conductivity can be derived from these resistancemeasurements. Further measurement columns 992, receiving the same fluid,may be added to provide additional fluid paths between additionalconductive electrode pairs, such as A-E, A-F, E-F, E-H and so on.Additional conductive electrodes may also be added to each measurementcolumn such as the conductive electrodes labeled J through M in FIG.23B. In the latter example, additional conductive electrode pairs can beused for additional measurements of fluid conductivity, for example, A-Jand A-K. Not all combinations of conductive electrodes are enumeratedherein as it is straightforward to make a comprehensive list ofconductive electrode pairs that can be formed with any such aconductivity measurement system based on a desired number and allocationof conductive electrodes. As in the embodiment of FIG. 23A, branch linesthat admit diluent or concentrate may be included at any point, ofcourse with diminution of the number of combinations of conductingelectrodes that may be available for conductivity measurement.

In the foregoing embodiments, by forming multiple electrical conductionpaths through interconnected conductivity cells, using additionalconductive electrodes for each measurement column, and/or by measuringacross fluid paths between measurement columns, additional measurementsof the same fluid conductivity or measurements that include additionalvariables such as the electrode “wet-side resistance,” i.e., theresistance between an electrode and the fluid can be better gauged, atleast for purposes of determining the reliability of a conductivitymeasurement. Where a resistance measurement appears faulty due to anunexpected resistance associated with an electrode, the multiple pathsprovide multiple equations to solve for the unknown additionalresistance correction term that is used to compensate the resistance.The controller may perform these calculations automatically.

In any embodiments, an accumulator, such as accumulator 502, can beomitted and an inline pressure sensor alone may be employed therebyrelying on the compliance of tubing for providing smooth pressuresignals for control. The elimination or reduction in size of theaccumulator may be an optimization variable. Reducing this volume mayspeed the synchronization process.

In any of the embodiments, including the claims, two medicamentconcentrates may be diluted by a medicament proportioning system ormodule. In these arrangements where there is concentration detection,the buffer may be diluted first and then the acid may be diluted to forma dialysate or replacement fluid product. This has benefits in that theconcentration signal of the acid is stronger than that of the dilutebuffer thereby causing more sensitive concentration detection.

In any of the embodiments including cycler 106, the latter may bereplaced by any medicament consuming device or article such as a storagecontainer for product medicament or a peritoneal dialysis cycler. In anyof the foregoing embodiments, a pressure sensor 127 may be positionedwithin at an inlet or outlet of the accumulator to allow the controllerto control flow through the accumulator. This may in effect be amechanical pressure control signal from the device that demands fluidfrom any of the disclosed medicament proportioning system, medicamentproportioning module, or other device. See discussion of pressuretransducer 155 for relevant context and function for an example.

In any of the foregoing embodiments, the flow channels and pumpingmechanisms may be replaced with any equivalent elements adapted forfluid conveyance. They may be selected to handle flow rates in therange, in respective systems or in a single system to provide medicamentto a consuming device at a rate of 25 through 400 ml/min. Any of theembodiments may be modified to provide an intermediate storage ofmedicament if the instantaneous demand of a consuming device exceeds theselected maximum generation rate of medicament. The medicament formed bythe foregoing embodiments may be dialysate or replacement fluid for useany type of renal replacement therapy system, for example, peritonealdialysis, hemodialysis, liver dialysis, and hemofiltration. Theconsuming appliance for any of the above systems may be a storagecontainer to generate medicament to support a vacationing patient. Itwill be observed that in the embodiments disclosed, spent fluid (e.g.,spent dialysate) from an attached cycler can be disposed of such that itnever enters the medicament proportioning module 104 or any elementupstream of the cycler. In embodiments, the cycler 106 is configured toprevent a backflow of fluid into the medicament proportioning module104. For example, a check valve may be provided in-line between themedicament proportioning module 104 and cycler 106 for such a purpose.

By providing ultrapure water that has been reliably sterilized andguarded against touch contamination, it is possible to ensure againstrisk for a primed medicament proportioning module 104 to treat multiplepatients within a long time period, in an exemplary embodiment, up to 24hours apart. Also the medicament proportioning module 104 may be primedand readied for a treatment to occur many hours, for example up to 24hours, from the time of set-up.

In any of the foregoing cartridge embodiments, the cartridge may includea data carrier (e.g., 519) which may be or incorporate devices such as abar code, RFID, smart chip, memory chip, or other device that includesdata related to the concentrate or dry compound attached thereto forgeneration of medicament. Thus, by installing the cartridge, detailsrelated to the attached medicament concentrate can be communicated tothe controller of the medicament proportioning module 104 or medicamentpreparation system (e.g., 600). For example, the data carrier mayinclude data responsive to an expiration date, whether the fluid circuitattached to the cartridge has been used prior to the most recentinstallation, how much fluid has been generated from it, how long sinceit was first primed with fluid, the makeup of the concentrates attachedto the fluid circuit. The pre-attachment of the concentrates to thecircuit cartridge (e.g., 500, cartridge 406 and others), when thecartridge includes a data carrier that refers to information about theconcentrates and other components of the fluid circuit, provides the twobenefits (1) of allowing the cartridge, which may be of a types that isregistered in a specific position and therefore convenient to allow forreading of data on the data carrier by means of a reader and (2)preventing contamination of fluid circuit by avoiding the need to make anew connection to combine the concentrate containers with the otherelements of the fluid circuit. The precise positioning of the cartridge,for engagement of actuators and sensors therewith, can ensurepredictable and reliable interaction between the data carrier and areader co-located with the sensors and actuators. Also, the cartridgemay be of a type that is convenient and relatively small, makinghandling easier for less able-bodied users, since the cartridge may betethered to the heavier concentrate containers which may be placed inseparate positions and, in embodiments, with less accuracy. Inembodiments, a receiving support for the concentrate containers may below down next to the floor while the cartridge receiving position may belocated above that receiving support for the concentrate containers. Seefor example the configuration shown in FIG. 13A where the medicamentconcentrate disposable package 617, which may contain the medicamentconcentrates as discussed with reference to the various embodiments, ispositioned on a low shelf. A slide out tray (on roller rails forexample) may be provided (not shown) to allow the medicament concentratedisposable package 617 to rested thereon so that the medicamentconcentrate disposable package 617 can be pushed into position withoutsliding. Similarly for the ultrafilter module 616 and any other similarcomponents.

The controller of the medicament proportioning module 104 or medicamentpreparation system 700 or any other of the modules or systems hereindescribed may have an identifier of one or more patients correlated withthe medicament that is prescribed for that patient. The data included inthe data carrier may be used by the controller to confirm that thecorrect fluid circuit is loaded by verifying the circuit cartridge datacarrier. The control of the proportioning by pumps may be regulated toconform to the required medicament product. When the cycler is attachedto the medicament preparation system (e.g., 600) or module 104, a signalcommunication between the controller of the medicament proportioningmodule 104 or medicament preparation system 700 and the attachedconsuming device, such as cycler 106 (e.g., see lines 124) may containdata indicating the type of medicament required, an identification ofthe patient, a prescription, or other information that may be correlatedby any of the controller with the parameters of the connected fluidcircuit as indicated on the data carrier of the cartridge and a signalindicating permitted or non-permitted component installation generatedby any of the controllers. Such a signal may cause the generation of anoutput indication or prevent further operation of the equipment, if anon-permitted component installation is performed.

The data carrier may also establish expected reading ranges for measuredconcentration of medicament concentrate indicated by concentrationmeasurement module 535A-535D. These data may be used to control thedilution rate of the respective medicament concentrates using feedbackcontrol from the concentration measurement modules orconductivity/temperature sensors in accord with the respectiveembodiments. Note that as used herein, a combination of a conductivitysensor and a temperature sensor may also be referred to as aconcentration measurement module for example the combinations shown inFIGS. 8A and 8B. The data carrier may include calibration data or dataused for ensuring the accuracy of measurement using the cartridge orother parts of the fluid circuit. For example, in embodiments, the datacarrier may communicate to the controller the cell constants ordimensions of the conductivity sensors of the cartridge for use incomputing conductivity and thereby concentration. The data relating todisposables attached to and used with the system (e.g., waterpurification module 102 and medicament proportioning module 104) may belogged in a maintenance and/or procedure log for troubleshooting andservice. The latter may be output by the user interface by maintenance,treatment, or service personnel. Solute concentration is used to settarget conductivity values. Reading in solute concentration allowsaddition of new catalogue numbers without requiring a software update.[not clear what this means]

The replaceable components used for water purification may includereplaceable tagged components with data carriers permitting varioussimilar functions as the data carriers 519 and other relevant to thecartridge. Generally, the function of the water purification module 102(or the water purifying function of an integrated medicament preparationsystem), is to purify water to a same standard. However the performancecharacteristics of the replaceable tagged components may vary. Thecontrol of the water purification module 102 may include determiningwhether the replaceable tagged component is correct for the particularwater purification module 102. In embodiments the controller may predicta total amount of fluid that may be processed before replacement ofcertain replaceable tagged components is appropriate.

Referring now to FIG. 23A, a conductivity measurement portion 990A of afluid circuit includes multiple measurement columns 992 connected inseries by channel elements 993, 995, 997. Additional junctions may beprovided as described in reference to FIG. 10. Four pairs of conductiveelectrodes A-B, C-D, E-F, G-H are shown but the number of columns andnumber of electrodes can vary. As described with reference to FIG. 10,each conductive electrode pair can be used for an independentmeasurement of a conductivity of fluid (or fluids) flowing therethrough.In the present embodiments, resistance is measured across other pairs ofconductive electrodes than the pairs, A-B, for example, at opposite endsof each measurement column 992. For example, the resistance betweenconductive electrodes A-C and A-D as well as B-C and B-D may also bemeasured. With predefined channel properties between these pairs ofconductive electrodes stored in a controller (or effectively stored in alookup table or formula for computing fluid conductivity, multipleequations with multiple unknowns that include the contact resistances ofthe electrical contacts used to measure conductivity can be obtained.

In any of the foregoing embodiments, fluid circuits may include inlinechambers (accumulators) to reduce water hammer due to interactionbetween interconnected peristaltic pumps. Additional (extra—more thanrequired) lengths of tubing may also be included the same purpose. Also,tubing diameters of pump tubing segments may be selected to minimizeinteraction issues which may reduce accuracy or cause breakage ofcircuit elements.

According to first embodiments, the disclosed subject matter includes afluid circuit for preparation of a medicament for renal replacementtherapy. A flexible bag contains acid concentrate connected for flowcommunication, through a first pumping tube segment, to a medicamentsupply line that has been capped and sterile-sealed at an outlet endthereof. A bicarbonate cartridge contains dry bicarbonate buffercompound. The bicarbonate cartridge is of a type that admits water in acartridge inlet thereby forming a saturated bicarbonate solution whichis received at a cartridge outlet. The cartridge outlet is connected forflow communication, through a second pumping tube segment, to themedicament supply line. A water inlet line is capped and sterile-sealedand connected for flow communication, through a third pumping tubesegment, to the medicament supply line and further connected for flowcommunication to the bicarbonate cartridge inlet. The first, second, andthird pumping tube segments are supported by a circuit cartridge whichorients, aligns, and exposes for access the first, second, and thirdpumping tube segments with respective actuators of a predefinedmedicament preparation device. The circuit cartridge contains a firstconcentration sensor station positioned in the medicament supply linedownstream of a first junction where a first of the first and secondpumping tube segments connects to the medicament supply line. Thecircuit cartridge contains a second concentration sensor stationpositioned in the medicament supply line downstream of both the firstjunction and a second junction where a second of the first and secondpumping tube segments connects to the medicament supply line.

The entire fluid circuit is sterile. In embodiments, the entire fluidcircuit is sealed and sterilized as a unit so that there is no need toconnect the medicament containers to the rest of the fluid circuit andthe only opportunities for ingress of contaminants into the fluidcircuit is through a sterile filter, which prevents ingress ofcontaminating bacteria. Since other connections are outlets only, forexample for product dilute medicament and waste, the pumping ensuresthat bacteria cannot otherwise enter.

Variations of the first embodiments may be provided to form additionalfirst embodiments in which the circuit cartridge includes a fluidaccumulator fluidly coupled between the water inlet line and themedicament supply line outlet end that includes a pressure-regulatingurging element that biases a flexible wall of the accumulator such thattransient changes of fluid pressure therein cause expansion of thevolume of the accumulator. Variations of the first embodiments may beprovided to form additional first embodiments in which the fluid circuitis packaged with a box such that the circuit cartridge can be detachedor removed from the box while leaving the flexible bag and bicarbonatecartridge intact therein with lengths of connecting lines between thecircuit cartridge and the box, thereby permitting the circuit cartridgeto be installed in a position remote form a position where the box isinstalled. Variations of the first embodiments may be provided to formadditional first embodiments in which the fluid circuit is packagedwithin a box such that the circuit cartridge can be removed from the boxwhile leaving the flexible bag and bicarbonate cartridge intact thereinwith lengths of connecting lines between the circuit cartridge and thebox, thereby permitting the circuit cartridge to be installed in aposition remote form a position where the box is installed.

Further variations of the first embodiments may be provided to formadditional first embodiments in which the fluid circuit is attached to abox in such a way that the circuit cartridge can be detached from thebox while leaving the flexible bag and bicarbonate cartridge intacttherein with lengths of connecting lines between the circuit cartridgeand the box, thereby permitting the circuit cartridge to be installed ina position remote form a position where the box is installed. TheVariations of the first embodiments may be provided to form additionalfirst embodiments in which the box is principally of cardboard.Variations of the first embodiments may be provided to form additionalfirst embodiments in which each of the concentration sensor stationsincludes a liquid conductivity sensor and temperature sensor portions.Variations of the first embodiments may be provided to form additionalfirst embodiments in which the temperature sensor portion includes aflow chamber with a flat surface to permit a temperature sensor to beplaced against the flat surface of a predefined sensor of the predefinedmedicament preparation device. Variations of the first embodiments maybe provided to form additional first embodiments in which each of theconcentration stations includes, connected in series, two independentconductivity sensors and two independent temperature sensor portions.Variations of the first embodiments may be provided to form additionalfirst embodiments in which the medicament supply line includes a wasteoutlet branch that is in direct fluid communication with theaccumulator, the waste outlet line is capped and sterile-sealed, themedicament supply line outlet line and waste outlet branches haspinching portions supported in an open section of the circuit cartridgeto permit access by pinching actuators.

According to second embodiments, the disclosed subject matter includes afluid circuit for preparation of a medicament for renal replacementtherapy. A first container contains acid concentrate connected for flowcommunication, through a first pumping tube segment, to a medicamentsupply line that has been capped and sterile-sealed at an outlet endthereof.

A second container contains a buffer concentrate connected for flowcommunication, through a second pumping tube segment, to the medicamentsupply line. A water inlet line is capped and sterile-sealed andconnected for flow communication, through a third pumping tube segment,to the medicament supply line. The first, second, and third pumping tubesegments are supported by a circuit cartridge which orients, aligns, andexposes for access the first, second, and third pumping tube segmentswith respective actuators of a predefined medicament preparation device.The circuit cartridge contains a first concentration sensor stationpositioned in the medicament supply line downstream of a first junctionwhere a first of the first and second pumping tube segments connects tothe medicament supply line. The circuit cartridge contains a secondconcentration sensor station positioned in the medicament supply linedownstream of both the first junction and a second junction where asecond of the first and second pumping tube segments connects to themedicament supply line.

The entire fluid circuit is sterile. In embodiments, the entire fluidcircuit is sealed and sterilized as a unit so that there is no need toconnect the medicament containers to the rest of the fluid circuit andthe only opportunities for ingress of contaminants into the fluidcircuit is through a sterile filter, which prevents ingress ofcontaminating bacteria. Since other connections are outlets only, forexample for product dilute medicament and waste, the pumping ensuresthat bacteria cannot otherwise enter.

Variations of the second embodiments may be provided to form additionalsecond embodiments in which the circuit cartridge includes a fluidaccumulator fluidly coupled between the water inlet line and themedicament supply line outlet end that includes a pressure-regulatingurging element that biases a flexible wall of the accumulator such thattransient changes of fluid pressure therein cause expansion of thevolume of the accumulator. Variations of the second embodiments may beprovided to form additional second embodiments in which the fluidcircuit is packaged with a box such that the circuit cartridge can bedetached or removed from the box while leaving the first and secondcontainers intact therein with lengths of connecting lines between thecircuit cartridge and the box, thereby permitting the circuit cartridgeto be installed in a position remote form a position where the box isinstalled. Variations of the second embodiments may be provided to formadditional second embodiments in which the fluid circuit is packagedwithin a box such that the circuit cartridge can be removed from the boxwhile leaving the first and second containers intact therein withlengths of connecting lines between the circuit cartridge and the box,thereby permitting the circuit cartridge to be installed in a positionremote form a position where the box is installed.

Further variations of the second embodiments may be provided to formadditional second embodiments in which the fluid circuit is attached toa box in such a way that the circuit cartridge can be detached from thebox while leaving the first and second containers intact therein withlengths of connecting lines between the circuit cartridge and the box,thereby permitting the circuit cartridge to be installed in a positionremote form a position where the box is installed. The Variations of thesecond embodiments may be provided to form additional second embodimentsin which the box is principally of cardboard. Variations of the secondembodiments may be provided to form additional second embodiments inwhich each of the concentration sensor stations includes a liquidconductivity sensor and temperature sensor portions. Variations of thesecond embodiments may be provided to form additional second embodimentsin which the temperature sensor portion includes a flow chamber with aflat surface to permit a temperature sensor to be placed against theflat surface of a predefined sensor of the predefined medicamentpreparation device. Variations of the second embodiments may be providedto form additional second embodiments in which each of the concentrationstations includes, connected in series, two independent conductivitysensors and two independent temperature sensor portions. Variations ofthe second embodiments may be provided to form additional secondembodiments in which the medicament supply line includes a waste outletbranch that is in direct fluid communication with the accumulator, thewaste outlet line is capped and sterile-sealed, the medicament supplyline outlet line and waste outlet branches has pinching portionssupported in an open section of the circuit cartridge to permit accessby pinching actuators.

According to third embodiments, the disclosed subject matter includes afluid handling system. A multiple stage water filtration module has afluid circuit with a pump positioned in the fluid circuit to pump watertherethrough, an inlet, an outlet, and at least two filtration stageseach has a replaceable filter component. A controller has a signaloutput and a water quality sensor connected to fluid circuit andpositioned to detect the quality of water upstream of the at least twofiltration stages and output a water quality signal. The controllerfurther has a signal output and further is connected to control thepump. the controller includes a processor and a data store, theprocessor is programmed to generate cumulative load data, stored in thedata store and indicative of a cumulative amount of filterable materialin water processed through the fluid circuit up to a point of time priorto a change of at least one of the replaceable filter components,wherein the cumulative load data is responsive to multiple samples ofthe water quality signal. The controller generating a control or dataoutput signal responsive to the cumulative load data for use inreplacing the at least one of the replaceable filter components.

Further variations of the third embodiments may be provided to formadditional third embodiments in which the water quality sensor includesa water conductivity sensor. Further variations of the third embodimentsmay be provided to form additional third embodiments in which thecontroller prevents operation of the pump until the at least one of thereplaceable filter components is changed. Further variations of thethird embodiments may be provided to form additional third embodimentsin which the at least one of the replaceable filter components includesa deionization filter. Further variations of the third embodiments maybe provided to form additional third embodiments in which the at leastone of the replaceable filter components includes an activated carbonfilter. Further variations of the third embodiments may be provided toform additional third embodiments in which the control or data outputsignal includes data indicating an amount of time before the at leastone of the replaceable filter components is exhausted. Furthervariations of the third embodiments may be provided to form additionalthird embodiments in which the control or data output signal includes auser interface output indicating that the at least one of thereplaceable filter components should be changed. Further variations ofthe third embodiments may be provided to form additional thirdembodiments in which the cumulative load data is responsive to a totalvolume of water processed by the at least one of the replaceable filtercomponents. Further variations of the third embodiments may be providedto form additional third embodiments in which the total volume isindicated by the operating time or number of cycles of the pump.

According to fourth embodiments, the disclosed subject matter includes amedicament preparation system. A fluid management element has acontroller, pump actuators, sensors, a valve actuator, a data reader,and a cartridge support for a fluid handling cartridge. The fluidmanagement element has a support for a medicament concentrate containerpositioned remotely from the cartridge support. The data reader islocated adjacent the cartridge support so as to permit the reading of adata carrier on a cartridge positioned to engage the pump actuators,sensors, and valve actuator. The controller is configured to store dataread by the data reader indicating a characteristic of concentrate inthe medicament concentrate container and to control the fluid managementelement responsively thereto.

Further variations of the fourth embodiments may be provided to formadditional fourth embodiments that include a replaceable fluid circuitwith a medicament concentrate container and a fluid handling cartridge,the fluid handling cartridge has pumping tube segments sized and shapedto engage the pump actuators and a data carrier positioned to conveydata to the data reader. Further variations of the fourth embodimentsmay be provided to form additional fourth embodiments in which the datacarrier includes a bar code. Further variations of the fourthembodiments may be provided to form additional fourth embodiments inwhich the fluid handling cartridge and the medicament concentratecontainer are connected by one or more tubes which allow the fluidhandling cartridge to be installed in the fluid management elementremotely from the fluid handling cartridge. The Further variations ofthe fourth embodiments may be provided to form additional fourthembodiments in which the controller includes a processor programmed tocompare the characteristics of concentrate with predefinedcharacteristic data stored by the controller and to output dataresponsive to the comparison, the controller controlling the fluidmanagement element responsively to a result of the comparison. Furthervariations of the fourth embodiments may be provided to form additionalfourth embodiments in which the controller includes a user interface anda processor programmed to compare the characteristics of concentratewith predefined characteristic data stored by the controller and tooutput data responsive to the comparison, the processor outputting datato the user interface responsive to a result of the comparison, includesindicting a correct or incorrect type of medicament concentrate in themedicament concentrate container. Further variations of the fourthembodiments may be provided to form additional fourth embodiments inwhich the concentrate container includes an acid and a buffer. Furthervariations of the fourth embodiments may be provided to form additionalfourth embodiments in which the data carrier includes an RFID. Furthervariations of the fourth embodiments may be provided to form additionalfourth embodiments in which the fluid handling cartridge includestemperature sensor portions that are aligned with temperature sensorswhen the cartridge is with respect to the cartridge such that the datareader is able to read data from the data carrier. Further variations ofthe fourth embodiments may be provided to form additional fourthembodiments in which the fluid handling cartridge is removably housedwithin in the medicament concentrate container. Further variations ofthe fourth embodiments may be provided to form additional fourthembodiments in which the fluid handling cartridge is removably attachedto the medicament concentrate container.

According to fifth embodiments, the disclosed subject matter includes amedicament preparation system. A medicament generation system hasactuators and sensors positioned and shaped to interface a fluidcircuit. The fluid circuit includes a first container contains acidconcentrate connected for flow communication, through a first pumpingtube segment, to a medicament supply line that has been capped andsterile-sealed at an outlet end thereof; a second container contains abuffer concentrate connected for flow communication, through a secondpumping tube segment, to the medicament supply line; and a water inletline of the medicament supply line, capped and sterile-sealed, connectedfor flow communication, through a third pumping tube segment, to themedicament supply line. A sterile filter in the water inlet line ispositioned to filter all water entering the medicament supply line. Thefluid circuit is disposable replaceable component and provided as asterile sealed unit. A water purification plant is connectable to theinlet, the water purification plant has a sterile filter positioned inan outlet thereof, which is connectable to the inlet, has a pore sizethat ensures sterility of the water entering the water inlet line. Acontroller has a processor configured to calculate a permissible lifefor utilization thereof responsively to at least one of a volume offluid passing through the medicament supply line, a volume of waterpassing through the water inlet, and a length of time since water firstflowed through the water inlet.

Further variations of the fifth embodiments may be provided to formadditional fifth embodiments in which the first, second, and thirdpumping tube segments are supported by a circuit cartridge whichorients, aligns, and exposes for access the first, second, and thirdpumping tube segments with respective actuators of a predefinedmedicament preparation device. Further variations of the fifthembodiments may be provided to form additional fifth embodiments inwhich the circuit cartridge contains a first concentration sensorstation positioned in the medicament supply line downstream of a firstjunction where a first of the first and second pumping tube segmentsconnects to the medicament supply line. Further variations of the fifthembodiments may be provided to form additional fifth embodiments inwhich the circuit cartridge contains a second concentration sensorstation positioned in the medicament supply line downstream of both thefirst junction and a second junction where a second of the first andsecond pumping tube segments connects to the medicament supply line.Further variations of the fifth embodiments may be provided to formadditional fifth embodiments in which the circuit cartridge contains asecond concentration sensor station positioned in the medicament supplyline downstream of both the first junction and a second junction where asecond of the first and second pumping tube segments connects to themedicament supply line.

Further variations of the fifth embodiments may be provided to formadditional fifth embodiments in which the circuit cartridge includes afluid accumulator fluidly coupled between the water inlet line and themedicament supply line outlet end that includes a pressure-regulatingurging element that biases a flexible wall of the accumulator such thattransient changes of fluid pressure therein cause expansion of thevolume of the accumulator. Further variations of the fifth embodimentsmay be provided to form additional fifth embodiments in which the fluidcircuit is packaged with a box such that the circuit cartridge can bedetached or removed from the box while leaving the first and secondcontainers therein with lengths of connecting lines between the circuitcartridge and the box, thereby permitting the circuit cartridge to beinstalled in a position remote form a position where the box isinstalled. Further variations of the fifth embodiments may be providedto form additional fifth embodiments in which the fluid circuit ispackaged within a box such that the circuit cartridge can be removedfrom the box while leaving the first and second containers therein withlengths of connecting lines between the circuit cartridge and the box,thereby permitting the circuit cartridge to be installed in a positionremote form a position where the box is installed. Further variations ofthe fifth embodiments may be provided to form additional fifthembodiments in which the fluid circuit is attached to a box in such away that the circuit cartridge can be detached from the box whileleaving the first and second containers therein with lengths ofconnecting lines between the circuit cartridge and the box, therebypermitting the circuit cartridge to be installed in a position remoteform a position where the box is installed.

Still further variations of the fifth embodiments may be provided toform additional fifth embodiments in which the box is principally ofcardboard. Further variations of the fifth embodiments may be providedto form additional fifth embodiments in which each of the concentrationsensor stations includes a liquid conductivity sensor and temperaturesensor portions. Further variations of the fifth embodiments may beprovided to form additional fifth embodiments in which the temperaturesensor portion includes a flow chamber with a flat surface to permit atemperature sensor to be placed against the flat surface of a predefinedsensor of the predefined medicament preparation device. Furthervariations of the fifth embodiments may be provided to form additionalfifth embodiments in which each of the concentration stations includes,connected in series, two independent conductivity sensors and twoindependent temperature sensor portions. Further variations of the fifthembodiments may be provided to form additional fifth embodiments inwhich the medicament supply line includes a waste outlet branch that isin direct fluid communication with the accumulator, the waste outletline is capped and sterile-sealed, the medicament supply line outletline and waste outlet branches has pinching portions supported in anopen section of the circuit cartridge to permit access by pinchingactuators.

According to sixth embodiments, the disclosed subject matter includes amedicament preparation system. A water purification module and amedicament proportioning module are housed together in a single housingof generally cubic shape with a maximum dimension of less than 0.8 m.The water purification module has a carbon filter, a two stagedeionization filter, the first stage has separate cation and anion beds.A second stage has a mixed cation-anion bed, each of the carbon filter.The cation and anion beds and the mixed cation-anion bed is in fourrespective cylindrical containers whose lengths are within 80% of themaximum dimension and receivable with their respective axes verticallyaligned in respective support bays located with a pair of each of thefour on, and accessible from, an opposite face of the housing. Anultraviolet filter, a heater, a sediment filter, and an air breakoccupying a volume between the two pairs of cylindrical containers.Adjacent and to the side of the volume, or within the volume, is acontrol module stacked atop a replaceable component receiving space. Thereplaceable component receiving space is open to one of the faces andhousing a medicament concentrate container. The control module hasactuators and sensors and a receiving opening sized for a predefinedfluid circuit cartridge with which the pumping actuators and sensorsengage and a user interface facing the one of the faces. The controlleris programmed to control pumping actuators to mix water from the waterpurification module with concentrate from a medicament concentratecontainer in a prescribed ratio to generate a product medicament.

Variations of the sixth embodiments may be provided to form additionalsixth embodiments having a fluid circuit that includes a medicamentconcentrate and a fluid circuit cartridge interconnected by a length oftubing that permits the cartridge to be inserted in the receivingopening and the medicament concentrate to be inserted in the replaceablecomponent receiving space without connecting or disconnecting. The fluidcircuit is a product of a process according to which the fluid circuitcartridge and medicament concentrate have been interconnected and sealedfrom the external environment and thereafter sterilized as a unit.Variations of the sixth embodiments may be provided to form additionalsixth embodiments in which the medicament concentrate is stored within afirst container containing acid concentrate and a second containercontaining a buffer concentrate, the first container is connected forflow communication, through a first pumping tube segment, to amedicament supply line that has been capped and sterile-sealed at anoutlet end thereof and the second container is connected for flowcommunication, through a second pumping tube segment, to the medicamentsupply line. Variations of the sixth embodiments may be provided to formadditional sixth embodiments in which the fluid circuit further includesa water inlet line connected for flow communication, through a thirdpumping tube segment, to the medicament supply line. Variations of thesixth embodiments may be provided to form additional sixth embodimentsin which the fluid circuit cartridge contains a first concentrationsensor station positioned in the medicament supply line downstream of afirst junction where a first of the first and second pumping tubesegments connects to the medicament supply line. Variations of the sixthembodiments may be provided to form additional sixth embodiments inwhich the fluid circuit cartridge containing a second concentrationsensor station positioned in the medicament supply line downstream ofboth the first junction and a second junction where a second of thefirst and second pumping tube segments connects to the medicament supplyline. Variations of the sixth embodiments may be provided to formadditional sixth embodiments in which the fluid circuit cartridgeincludes a fluid accumulator fluidly coupled between the water inletline and the medicament supply line outlet end that includes apressure-regulating urging element that biases a flexible wall of theaccumulator such that transient changes of fluid pressure therein causeexpansion of the volume of the accumulator. Variations of the sixthembodiments may be provided to form additional sixth embodiments inwhich the fluid circuit is packaged within a box such that the fluidcircuit cartridge can be removed from the box while leaving the firstand second containers therein with lengths of connecting lines betweenthe fluid circuit cartridge and the box. Variations of the sixthembodiments may be provided to form additional sixth embodiments inwhich the fluid circuit is attached to a box in such a way that thecircuit cartridge can be detached from the box while leaving the firstand second containers therein with lengths of connecting lines betweenthe fluid circuit cartridge and the box. Variations of the sixthembodiments may be provided to form additional sixth embodiments inwhich each of the concentration stations includes, connected in series,two independent conductivity sensors and two independent temperaturesensor portions.

According to seventh embodiments, the disclosed subject matter includesa medicament preparation system. A fluid circuit cartridge has a productmedicament output port and a first pumping tube segment connectable to apure water supply and the product medicament output port. Respectivefirst and second concentrate containers are connected by second andthird pumping tube segments to the medicament output port at respectivefirst and second junctions. A first concentration measurement sensorstation positioned a flow path of the fluid circuit cartridge betweenthe first and second junctions. A second concentration measurementstation is positioned in the flow path of the fluid circuit cartridgebetween the second junction and the product medicament output port. Acontroller is programmed to calculate iteratively a concentration of thefirst concentrate and water from a signal generated by the firstconcentration measurement station and to regulate a one or both of afirst pumping actuator engaged with the first pumping tube segment and asecond pumping actuator engaged with the pump second pumping tubesegment responsively to the concentration of the first concentrate andwater. The controller is programmed to calculate iteratively aconcentration of the second concentrate and the first concentrate andwater from a signal generated by the second concentration measurementstation and to regulate at least two of the first, second pumpingactuators and a third pumping actuator engaged with the third pumpingtube segment responsively to the concentration of the first and secondconcentrates and water.

According to eighth embodiments, the disclosed subject matter includes afluid circuit. A planar member has a pattern of uniform fluid channelsformed therein, has a water inlet and generally uniform cross-section,and defining a product solution channel with multiple concentrationmeasurement stations therealong, each following a respective one ofjunctions at which respective solutes are injected into the productsolution channel. Each concentration measurement station including aninlet opening in the planar member defining a passage between a portionof the uniform fluid channels and an expanded fluid flow column. Thecolumn channel has electrodes spaced apart along the column. Eachconcentration measurement station further including an outlet opening inthe planar member defining a passage between a first portion of theuniform fluid channels and the expanded fluid flow column. The inlet andoutlet openings are at opposite ends of the fluid flow column. Theoutlet opening leading from the fluid flow column into an expandedsection of the fluid channels has a flat face covered by a film, and theoutlet opening is at an edge of the expanded section. A return openingopposite the outlet opening leading to a second portion of the uniformfluid channels downstream from the first portion. The electrodes hasflat external contact surfaces that are parallel to the flat face suchthat electrical contacts and a temperature probe can be brought intothermal and electrical contact by moving the fluid circuit in adirection that is perpendicular to the flat face and the externalcontact surfaces relative to electrical contacts and a temperaturesensor until thermal and electrical contact is made.

Variations of the eighth embodiments may be provided to form additionaleighth embodiments in which the concentration measurement stations arearranged pairs to permit redundant concentration measurement of a flowfollowing each of the junctions.

Variations of the eighth embodiments may be provided to form additionaleighth embodiments in which the junctions are connected to medicamentconcentrate containers. Variations of the eighth embodiments may beprovided to form additional eighth embodiments in which the junctionsare connected to medicament concentrate containers containingconcentrate, the fluid circuit is a product of a process that includesfilling the concentrate containers with medicament concentrates ofdifferent compounds, sealing the fluid circuit from the externalenvironment, sterilizing the filled and sealed fluid circuit, andpackaging it as sealed sterilized unit for storage or delivery.Variations of the eighth embodiments may be provided to form additionaleighth embodiments in which the process further includes filling theconcentrate containers through one or more sterile filters attached tocontainers through a fill line and welding the fill line shut to sealthem. Variations of the eighth embodiments may be provided to formadditional eighth embodiments in which one of the junctions is connectedto medicament concentrate container containing concentrate and the otheris connected to a dry buffer cartridge outlet, an inlet of the drybuffer cartridge is connected to the water inlet, the fluid circuit is aproduct of a process that includes filling the concentrate containerswith medicament concentrates of different compounds, sealing the fluidcircuit from the external environment, sterilizing the filled and sealedfluid circuit, and packaging it as sealed sterilized unit for storage ordelivery.

According to ninth embodiments, the disclosed subject matter includes amedicament preparation system. A housing contains a water purificationmodule that includes multiple filtration stages. A medicamentproportioning module is connected to receive purified product watergenerated by the water purification module and to dilute medicamentconcentrate in predefined proportions to generate a predefinedmedicament at a medicament product outlet. The housing hasoutwardly-facing receiving bays for filter media containerscorresponding respectively to the multiple filtration stages. Thehousing has housing fluid connectors for connecting to the containersand the filter media containers has container connectors. Each filtermedia container has a guide engagement portion that fit into respectiveguides of the housing to force the each filter media container into anorientation and vertical position that aligns the housing and containerfluid connectors.

Variations of the ninth embodiments may be provided to form additionalninth embodiments in which the filter media containers contain,respectively, carbon filtration and separated-bed and mixed beddeionization filter beds. Variations of the ninth embodiments may beprovided to form additional ninth embodiments in which the receivingbays have recessed receiving support fixtures arranged to permit thebottom of each of the filter media containers to be inserted in thereceiving support fixtures first and tilted to a position where theguide engagement portion fit into the respective guides of the housing.Variations of the ninth embodiments may be provided to form additionalninth embodiments in which the housing connectors have urging devicesthat urge the container connectors away from them. Variations of theninth embodiments may be provided to form additional ninth embodimentsthat include a water quality sensor positioned to detect the quality ofwater received by the water purification module and a programmablecontroller programmed to output a limit signal used to limit the amountof water processed through the water purification module responsively tohistorical data responsive to the water quality indication over time anddata indicating characteristics of media of the filter media containers.Variations of the ninth embodiments may be provided to form additionalninth embodiments in which the controller is programmed to limit theamount of water processed by controlling a pump responsively to thelimit signal. Variations of the ninth embodiments may be provided toform additional ninth embodiments in which the controller is programmedto limit the amount of water processed by outputting an error indicationon a user interface responsively to the limit signal. Variations of theninth embodiments may be provided to form additional ninth embodimentsthat include a first water quality sensor positioned to detect thequality of water received by the water purification module and a secondwater quality sensor positioned to detect the quality of water processedby the water purification module, and a programmable controllerprogrammed to output a limit signal used to limit the amount of waterprocessed through the water purification module responsively tohistorical data responsive to the water quality indication over time anddata indicating characteristics of media of the filter media containers.Variations of the ninth embodiments may be provided to form additionalninth embodiments in which the controller is programmed to limit theamount of water processed by controlling a pump responsively to thelimit signal. Variations of the ninth embodiments may be provided toform additional ninth embodiments in which the controller is programmedto limit the amount of water processed by outputting an error indicationon a user interface responsively to the limit signal. Variations of theninth embodiments may be provided to form additional ninth embodimentsin which the characteristics include data indicating whether the mediahave been used prior to installation thereof on the water purificationmodule. Variations of the ninth embodiments may be provided to formadditional ninth embodiments in which the characteristics include dataindicating whether the media have ever been exhausted prior toinstallation thereof on the water purification module. Variations of theninth embodiments may be provided to form additional ninth embodimentsthat include a data reader that reads data from data carriers installedon the filter media containers wherein the characteristics include datafrom the data carriers indicating whether the media have ever beenexhausted prior to installation thereof on the water purificationmodule.

According to tenth embodiments, the disclosed subject matter includes amedicament preparation system with a housing containing a waterpurification module that includes multiple filtration stages. Amedicament proportioning module is connected to receive purified productwater generated by the water purification module and to dilutemedicament concentrate in predefined proportions to generate apredefined medicament at a medicament product outlet thereof. Eachfilter media container has a data carrier with data indicatingcharacteristics of the each filter media container. The housing has adata reader that reads data from the data carriers installed on thefilter media containers.

Variations of the tenth embodiments may be provided to form additionaltenth embodiments in which the characteristics include data from thedata carriers indicating whether the media have ever been exhaustedprior to installation thereof on the water purification module.Variations of the tenth embodiments may be provided to form additionaltenth embodiments in which the characteristics include data indicatingwhether the media have ever been exhausted prior to installation thereofon the water purification module. Variations of the tenth embodimentsmay be provided to form additional tenth embodiments in which the filtermedia containers contain, respectively, carbon filtration andseparated-bed and mixed bed deionization filter beds. Variations of thetenth embodiments may be provided to form additional tenth embodimentsthat include a water quality sensor positioned to detect the quality ofwater received by the water purification module and a programmablecontroller programmed to output a limit signal used to limit the amountof water processed through the water purification module responsively tohistorical data responsive to the water quality indication over time andthe data indicating characteristics of media of the filter mediacontainers. Variations of the tenth embodiments may be provided to formadditional tenth embodiments in which the characteristics include datafrom the data carriers indicating whether the media have ever beenexhausted prior to installation thereof on the water purificationmodule. Variations of the tenth embodiments may be provided to formadditional tenth embodiments in which the characteristics include dataindicating whether the media have ever been exhausted prior toinstallation thereof on the water purification module. Variations of thetenth embodiments may be provided to form additional tenth embodimentsin which the filter media containers contain, respectively, carbonfiltration and separated-bed and mixed bed deionization filter beds.Variations of the tenth embodiments may be provided to form additionaltenth embodiments in which the controller is programmed to limit theamount of water processed by controlling a pump responsively to thelimit signal. Variations of the tenth embodiments may be provided toform additional tenth embodiments in which the controller is programmedto limit the amount of water processed by outputting an error indicationon a user interface responsively to the limit signal. Variations of thetenth embodiments may be provided to form additional tenth embodimentsthat include a first water quality sensor positioned to detect thequality of water received by the water purification module and a secondwater quality sensor positioned to detect the quality of water processedby the water purification module, and a programmable controllerprogrammed to output a limit signal used to limit the amount of waterprocessed through the water purification module responsively tohistorical data responsive to the water quality indication over time anddata indicating characteristics of media of the filter media containers.

Variations of the tenth embodiments may be provided to form additionaltenth embodiments in which the controller is programmed to limit theamount of water processed by controlling a pump responsively to thelimit signal. Variations of the tenth embodiments may be provided toform additional tenth embodiments in which the controller is programmedto limit the amount of water processed by outputting an error indicationon a user interface responsively to the limit signal. Variations of thetenth embodiments may be provided to form additional tenth embodimentsin which the characteristics include data indicating whether the mediahave been used prior to installation thereof on the water purificationmodule. Variations of the tenth embodiments may be provided to formadditional tenth embodiments in which the characteristics include dataindicating whether the media have ever been exhausted prior toinstallation thereof on the water purification module. The system ofclaim 99, wherein, the filter media containers contain at least one of acarbon filtration, separated-bed, and mixed bed deionization filterbeds.

According to eleventh embodiments, the disclosed subject matter includesa fluid circuit for preparation of a medicament for renal replacementtherapy. A concentrate container of concentrate connected for flowcommunication, through a first pumping tube segment, to a medicamentsupply line is capped and sterile-sealed at an outlet end thereof. Abicarbonate cartridge contains dry bicarbonate buffer compound, thecartridge is of a type that admits water into a cartridge inlet therebyforming a saturated bicarbonate solution which is received at acartridge outlet, the cartridge outlet is connected for flowcommunication, through a second pumping tube segment, to the medicamentsupply line. A water inlet line has a sterile filter positioned toensure that all water entering the fluid circuit passes therethrough,the water inlet is capped and sterile-sealed, and connected for flowcommunication, through a third pumping tube segment, to the medicamentsupply line and connected for flow communication to the bicarbonatecartridge inlet. The entire fluid circuit is a product of a process inwhich the entire circuit is pre-connected and sterile-sealed, sterilizedas a whole includes the bicarbonate cartridge and the concentratecontainer is either filled before the entire circuit is sterilized as awhole or a sterile filter is pre-connected to the fluid circuit which issterilized as a whole and the medicament concentrate is filled into thecontainer through the filter whereupon a channel between the containerand the filter is permanently sealed in such a way that no contaminantscan thereafter enter the fluid circuit.

Variations of the eleventh embodiments may be provided to formadditional eleventh embodiments in which the first, second, and thirdpumping tube segments are supported by a circuit cartridge whichorients, aligns, and exposes for access the first, second, and thirdpumping tube segments with respective actuators of a predefinedmedicament preparation device. Variations of the eleventh embodimentsmay be provided to form additional eleventh embodiments in which thecircuit cartridge containing a first concentration sensor stationpositioned in the medicament supply line downstream of a first junctionwhere a first of the first and second pumping tube segments connects tothe medicament supply line. Variations of the eleventh embodiments maybe provided to form additional eleventh embodiments in which the circuitcartridge containing a second concentration sensor station positioned inthe medicament supply line downstream of both the first junction and asecond junction where a second of the first and second pumping tubesegments connects to the medicament supply line. Variations of theeleventh embodiments may be provided to form additional eleventhembodiments in which the circuit cartridge includes a fluid accumulatorfluidly coupled between the water inlet line and the medicament supplyline outlet end that includes a pressure-regulating urging element thatbiases a flexible wall of the accumulator such that transient changes offluid pressure therein cause expansion of the volume of the accumulator.Variations of the eleventh embodiments may be provided to formadditional eleventh embodiments in which the fluid circuit is packagedwith a box such that the circuit cartridge can be detached or removedfrom the box while leaving the concentrate container and bicarbonatecartridge intact therein with lengths of connecting lines between thecircuit cartridge and the box, thereby permitting the circuit cartridgeto be installed in a position remote form a position where the box isinstalled. Variations of the eleventh embodiments may be provided toform additional eleventh embodiments in which the fluid circuit ispackaged within a box such that the circuit cartridge can be removedfrom the box while leaving the concentrate container and bicarbonatecartridge intact therein with lengths of connecting lines between thecircuit cartridge and the box, thereby permitting the circuit cartridgeto be installed in a position remote form a position where the box isinstalled. Variations of the eleventh embodiments may be provided toform additional eleventh embodiments in which the fluid circuit isattached to a box in such a way that the circuit cartridge can bedetached from the box while leaving the concentrate container andbicarbonate cartridge intact therein with lengths of connecting linesbetween the circuit cartridge and the box, thereby permitting thecircuit cartridge to be installed in a position remote form a positionwhere the box is installed. Variations of the eleventh embodiments maybe provided to form additional eleventh embodiments in which the box isprincipally of cardboard. The circuit of any of claims 102 through 105,wherein each of the concentration sensor stations includes a liquidconductivity sensor and temperature sensor portions. Variations of theeleventh embodiments may be provided to form additional eleventhembodiments in which the temperature sensor portion includes a flowchamber with a flat surface to permit a temperature sensor to be placedagainst the flat surface of a predefined sensor of the predefinedmedicament preparation device. Variations of the eleventh embodimentsmay be provided to form additional eleventh embodiments in which each ofthe concentration stations includes, connected in series, twoindependent conductivity sensors and two independent temperature sensorportions. Variations of the eleventh embodiments may be provided to formadditional eleventh embodiments in which the medicament supply lineincludes a waste outlet branch that is in direct fluid communicationwith the accumulator, the waste outlet line is capped andsterile-sealed, the medicament supply line outlet line and waste outletbranches has pinching portions supported in an open section of thecircuit cartridge to permit access by pinching actuators.

According to twelfth embodiments, the disclosed subject matter includesa fluid circuit for preparation of a medicament for renal replacementtherapy. The circuit includes least one container of concentrateconnected for flow communication, through at least one first pumpingtube segment respective for each of the at least one container, to amedicament supply line that has been capped and sterile-sealed at anoutlet end thereof. A water inlet line has a sterile filter positionedto ensure that all water entering the fluid circuit passes therethrough,the water inlet is capped and sterile-sealed, and connected for flowcommunication, through a second pumping tube segment, to the medicamentsupply line. The entire fluid circuit is a product of a process in whichthe fluid circuit is pre-connected and sterile-sealed, sterilized as awhole and the concentrate container is either filled before the entirecircuit is sterilized as a whole or a sterile filter is pre-connected toa filling port of each of the at least one container, the fluid circuitwhich is sterilized as a whole, and at least one medicament concentrateis filled into the at least one container through a respective one thesterile filters whereupon a channel between the container and the filteris permanently sealed in such a way that no contaminants can thereafterenter the fluid circuit.

Variations of the twelfth embodiments may be provided to form additionaltwelfth embodiments in which the first, second, and third pumping tubesegments are supported by a circuit cartridge which orients, aligns, andexposes for access the first, second, and third pumping tube segmentswith respective actuators of a predefined medicament preparation device.Variations of the twelfth embodiments may be provided to form additionaltwelfth embodiments in which the circuit cartridge containing a firstconcentration sensor station positioned in the medicament supply linedownstream of a first junction where a first of the first and secondpumping tube segments connects to the medicament supply line. Variationsof the twelfth embodiments may be provided to form additional twelfthembodiments in which the circuit cartridge containing a secondconcentration sensor station positioned in the medicament supply linedownstream of both the first junction and a second junction where asecond of the first and second pumping tube segments connects to themedicament supply line. Variations of the twelfth embodiments may beprovided to form additional twelfth embodiments in which the circuitcartridge includes a fluid accumulator fluidly coupled between the waterinlet line and the medicament supply line outlet end that includes apressure-regulating urging element that biases a flexible wall of theaccumulator such that transient changes of fluid pressure therein causeexpansion of the volume of the accumulator. Variations of the twelfthembodiments may be provided to form additional twelfth embodiments inwhich the fluid circuit is packaged with a box such that the circuitcartridge can be detached or removed from the box while leaving the atleast one container intact therein with lengths of connecting linesbetween the circuit cartridge and the box, thereby permitting thecircuit cartridge to be installed in a position remote form a positionwhere the box is installed. Variations of the twelfth embodiments may beprovided to form additional twelfth embodiments in which the fluidcircuit is packaged within a box such that the circuit cartridge can beremoved from the box while leaving the at least one container intacttherein with lengths of connecting lines between the circuit cartridgeand the box, thereby permitting the circuit cartridge to be installed ina position remote form a position where the box is installed. Variationsof the twelfth embodiments may be provided to form additional twelfthembodiments in which the fluid circuit is attached to a box in such away that the circuit cartridge can be detached from the box whileleaving the at least one container intact therein with lengths ofconnecting lines between the circuit cartridge and the box, therebypermitting the circuit cartridge to be installed in a position remoteform a position where the box is installed. Variations of the twelfthembodiments may be provided to form additional twelfth embodiments inwhich the box is principally of cardboard. The circuit of any of claims102 through 105, wherein each of the concentration sensor stationsincludes a liquid conductivity sensor and temperature sensor portions.Variations of the twelfth embodiments may be provided to form additionaltwelfth embodiments in which the temperature sensor portion includes aflow chamber with a flat surface to permit a temperature sensor to beplaced against the flat surface of a predefined sensor of the predefinedmedicament preparation device. Variations of the twelfth embodiments maybe provided to form additional twelfth embodiments in which each of theconcentration stations includes, connected in series, two independentconductivity sensors and two independent temperature sensor portions.Variations of the twelfth embodiments may be provided to form additionaltwelfth embodiments in which the medicament supply line includes a wasteoutlet branch that is in direct fluid communication with theaccumulator, the waste outlet line is capped and sterile-sealed, themedicament supply line outlet line and waste outlet branches haspinching portions supported in an open section of the circuit cartridgeto permit access by pinching actuators.

According to thirteenth embodiments, the disclosed subject matterincludes a compact medicament supply system to support blood treatmentsystems susceptible to leakage current from electric heater used to heatmedicament due to the inherent formation of a fluid path between theheater and the patient. A water purification module has a pump and acontroller, the water purification module has deionization filters ofsufficient capacity and the pump controlled to purify water to a levelof purity exceeding 1 megohm-cm and providing product water at at leastthat level of purity to a product water output connected to an electricheater. A water channel of a predefined length and of electricallyinsulating material connects the electric heater to a medicamentproportioning module disposable fluid circuit, the water channelreceiving the product water from the electric heater. The electricheater is of a configuration that places the product water in directcontact with permanent non-disposable surfaces of a flow channel in theelectric heater. A sterile filter is connected to receive the productwater at a point along the water channel, and the water channel has aoutput connector for connecting to the medicament proportioning system.The medicament proportioning system, principally of electricallyinsulating material, is connected to supply a conductive medicamentsolution to a treatment component connected to a patient via a bloodcircuit includes a patient access such that a continuous fluid pathbetween the electric heater and the patient access at times during atreatment. A controller is adapted for controlling the electric heaterresponsively to a measured temperature and temperature target selectedfor maintaining the body temperature of a human patient connected viathe blood circuit to the treatment component, the controllercompensating for heat load due the addition of medicament concentrate tothe flow of product water. A length of the water channel and aresistivity of the product water therein is sufficient to ensure thatthe electric heater produces less than 50 microamperes of leakagecurrent through the continuous fluid path to the patient access, wherebyheat required to maintain body temperature of a patient is treated by ablood treatment is provided through an electrically insulatingconvective flow of pure water used for the generation of medicament usedin the treatment.

Variations of the thirteenth embodiments may be provided to formadditional thirteenth embodiments in which the electric heater hasdouble-insulated heating elements.

According to fourteenth embodiments, the disclosed subject matterincludes a method for regulating a temperature of medicament forextracorporeal blood processing. The method includes providing purewater of a predefined resistivity. The method further includes using anelectric heating element, heating the pure water. The method furtherincludes flowing the purified water through an electrically insulatingchannel of such length and cross-section, and the predefined resistivityis such as to ensure that a leakage current of less than 50 microamperesreaches and end thereof. The method further includes diluting ordissolving medicament solute with a flow of the purified water startingat the end at a rate to achieve a concentration of a product medicamentresulting from the diluting or dissolving is suitable for immediate usein a blood treatment. The method further includes regulating a rate ofthe heating water to ensure that a temperature of the product maintainsa temperature of a human patient during an extracorporeal bloodtreatment that consumes the product medicament, whereby a resistivewater path is effective to electrically insulate the electric heatingelement from a patient receiving treatment to safeguard against a healthrisk from current leakage therefrom.

Variations of the fourteenth embodiments may be provided to formadditional fourteenth embodiments in which the providing includesdeionizing water to produce the pure water. Variations of the fourteenthembodiments may be provided to form additional fourteenth embodimentsthat include sterile-filtering the water prior to the diluting ordissolving. Variations of the fourteenth embodiments may be provided toform additional fourteenth embodiments in which the diluting ordissolving includes injecting medicament concentrate into a flow of purewater using a disposable fluid circuit. Variations of the fourteenthembodiments may be provided to form additional fourteenth embodimentsthat include regulating a rate of pure water production responsively tothe rate of consumption of medicament by the extracorporeal bloodtreatment. Variations of the fourteenth embodiments may be provided toform additional fourteenth embodiments that include regulating a patienttemperature by regulating a rate of heat addition to pure water thatwith a resistivity of at 100 kiloohm-cms. Variations of the fourteenthembodiments may be provided to form additional fourteenth embodimentsthat include regulating a rate of pure water production responsively tothe rate of consumption of medicament by the extracorporeal bloodtreatment. Variations of the fourteenth embodiments may be provided toform additional fourteenth embodiments that include regulating a rate ofpurified water production, the heat applied to purified water productionis proportional to a rate of heat addition to responsively to the rateof consumption of medicament by the extracorporeal blood treatment.

According to fifteenth embodiments, the disclosed subject matterincludes a mobile medicament supply system to support blood treatmentsystems susceptible to leakage current from electric heater used to heatmedicament due to the inherent formation of a fluid path between theheater and the patient. A source of pure water provides pure water witha resistivity exceeding 1 megohm-cm. The source is connected to anelectric heater. A water channel has a predefined length and ofelectrically insulating material connecting the electric heater to amedicament proportioning module disposable fluid circuit. The waterchannel receives the pure water from the electric heater. The medicamentproportioning system is principally of electrically insulating materialand connected to supply a conductive medicament solution to a treatmentcomponent connected to a patient via a blood circuit includes a patientaccess such that a continuous fluid path between the electric heater andthe patient access at times during a treatment. A controller is adaptedfor controlling the electric heater to achieve a target temperatureselected to maintain the body temperature of a human patient connectedvia the blood circuit to the treatment component, the controllerproviding additional heat to compensate for heat load resulting from thecooing effect of adding medicament concentrate to the flow of purewater. A length of the water channel, a cross-section thereof, and aresistivity of the pure water therein is sufficient to ensure that theelectric heater produces less than 50 microamperes of leakage currentthrough the continuous fluid path to the patient access, whereby heatrequired to maintain body temperature of a patient is treated by a bloodtreatment is provided through an electrically insulating convective flowof pure water used for the generation of medicament used in thetreatment.

Variations of the fifteenth embodiments may be provided to formadditional fifteenth embodiments in which the source of pure waterincludes a water purification module. Variations of the fifteenthembodiments may be provided to form additional fifteenth embodiments inwhich the water purification module has a pump and a controller.Variations of the fifteenth embodiments may be provided to formadditional fifteenth embodiments in which the water purification modulehas deionization filters of sufficient capacity to purify water to aresistivity exceeding 1 megohm-cm. Variations of the fifteenthembodiments may be provided to form additional fifteenth embodiments inwhich the electric heater is of a configuration that places the productwater in direct contact with permanent non-disposable surfaces of a flowchannel in the electric heater. Variations of the fifteenth embodimentsmay be provided to form additional fifteenth embodiments that include asterile filter connected to receive the pure water at a point along thewater channel, and the water channel has a output connector forconnecting to the medicament proportioning system. Variations of thefifteenth embodiments may be provided to form additional fifteenthembodiments in which the electric heater has double-insulated heatingelements.

According to sixteenth embodiments, the disclosed subject matterincludes a medicament proportioning system with a disposable fluidcircuit that has a generally planar element with a base portion and wallelements formed thereon. The wall elements define trough-shaped channelswhich are sealed by a film sealingly attached to the edges of the wallsopposite an edge of each wall that attaches to the base element toenclose the trough shaped channels. The trough shaped channels includeelongate portions that interconnect fluid circuit elements. First of thefluid circuit elements include widened portions of the trough shapedchannels that are positioned on the base portion to engage one or bothof temperature and pressure sensors of a predefined medicamentproportioning module. Second of the fluid circuit elements include atleast one pumping tube segment or at least one pinch-clamping actuatorof the predefined medicament proportioning module that engages with apumping actuator or pinch-clamping actuator of the predefined medicamentproportioning module. The second of the fluid circuit elements interfacewith a junction part defining a recess has an access and blind endspaced apart along an axis of the junction part recess that is parallelwith a major plane of the planar element base portion. An opening isformed in the planar element to form a fluid communication channelbetween each junction part recess and a region of the trough shapedchannels.

Variations of the sixteenth embodiments may be provided to formadditional sixteenth embodiments in which the second of the fluidcircuit elements has a tubular portion inserted in the junction partrecess, and the tubular portion has a longitudinal axis collinear withthe recess axis. Variations of the sixteenth embodiments may be providedto form additional sixteenth embodiments in which the second of thefluid circuit elements include at least one pumping tube segment thatengages with a pinch-clamping actuator of the predefined medicamentproportioning module. Variations of the sixteenth embodiments may beprovided to form additional sixteenth embodiments in which the troughshaped channels and the first fluid circuit elements are located on afirst major face of the planar element base portion that is opposite asecond major face, the second fluid circuit elements is attached to thesecond major face. Variations of the sixteenth embodiments may beprovided to form additional sixteenth embodiments in which the troughshaped channels and the first fluid circuit elements are located on afirst major face of the planar element base portion that is opposite asecond major face, the second fluid circuit elements is attached to thesecond major face.

Variations of the sixteenth embodiments may be provided to formadditional sixteenth embodiments that include third of the fluid circuitelements that include at least one column-shaped channel with electrodeson a side thereof, where the electrodes are positioned in the planarelement base portion and extend between a first major face of the planarelement base portion to an opposite second major face thereof.Variations of the sixteenth embodiments may be provided to formadditional sixteenth embodiments in which the trough shaped channels andthe first fluid circuit elements are located on the first major face ofthe planar element base portion and the second and third fluid circuitelements are attached to the second major face. Variations of thesixteenth embodiments may be provided to form additional sixteenthembodiments in which the column-shaped channel defines a recess has anaccess and blind end spaced apart along an axis of the column-shapedpart recess that is parallel with a major plane of the planar elementbase portion. Variations of the sixteenth embodiments may be provided toform additional sixteenth embodiments in which the column-shaped partrecess access is closed with an end plate. Variations of the sixteenthembodiments may be provided to form additional sixteenth embodiments inwhich the column-shaped channel defines a recess has an access and blindend spaced apart along an axis of the column-shaped part recess that isparallel with a major plane of the planar element base portion.Variations of the sixteenth embodiments may be provided to formadditional sixteenth embodiments in which the column-shaped part recessaccess is closed with an end plate. Variations of the sixteenthembodiments may be provided to form additional sixteenth embodiments inwhich the planar element has an opening to form a fluid communicationchannel between each column-shaped channel recess and a region of thetrough shaped channels.

Variations of the sixteenth embodiments may be provided to formadditional sixteenth embodiments in which the second of the fluidcircuit elements include at least one pumping tube segment that engageswith a pumping actuator of the predefined medicament proportioningmodule, wherein the trough shaped channels and the first fluid circuitelements are located on a first major face of the planar element baseportion that is opposite a second major face, the second fluid circuitelements is attached to the second major face, and the planar elementhas openings to permit actuators of the predefined medicamentproportioning module to reach from the first side to the second side toengage the at least one pumping tube segment. Variations of thesixteenth embodiments may be provided to form additional sixteenthembodiments in which the second of the fluid circuit elements include atleast one pinch tube segment that engages with a pinch clamp actuator ofthe predefined medicament proportioning module, wherein the troughshaped channels and the first fluid circuit elements are located on afirst major face of the planar element base portion that is opposite asecond major face, the second fluid circuit elements is attached to thesecond major face, and the planar element has openings to permitactuators of the predefined medicament proportioning module to reachfrom the first side to the second side to engage the at least one pinchtube segment. Variations of the sixteenth embodiments may be provided toform additional sixteenth embodiments in which the second of the fluidcircuit elements include at least one pumping tube segment that engageswith a pumping actuator of the predefined medicament proportioningmodule, wherein the trough shaped channels and the first fluid circuitelements are located on a first major face of the planar element baseportion that is opposite a second major face, the second fluid circuitelements is attached to the second major face, and the planar elementhas openings to permit actuators of the predefined medicamentproportioning module to reach from the first side to the second side toengage the at least one pumping tube segment. Variations of thesixteenth embodiments may be provided to form additional sixteenthembodiments in which the second of the fluid circuit elements include atleast one pinch tube segment that engages with a pinch clamp actuator ofthe predefined medicament proportioning module, wherein the troughshaped channels and the first fluid circuit elements are located on afirst major face of the planar element base portion that is opposite asecond major face, the second fluid circuit elements is attached to thesecond major face, and the planar element has openings to permitactuators of the predefined medicament proportioning module to reachfrom the first side to the second side to engage the at least one pinchtube segment. Variations of the sixteenth embodiments may be provided toform additional sixteenth embodiments that include third of the fluidcircuit elements that include at least one column-shaped channel withelectrodes on a side thereof, where the electrodes are positioned in theplanar element base portion and extend between a first major face of theplanar element base portion to an opposite second major face thereof.

Variations of the sixteenth embodiments may be provided to formadditional sixteenth embodiments that include third of the fluid circuitelements that include at least one column-shaped channel with electrodeson a side thereof, where the electrodes are positioned in the planarelement base portion and extend between a first major face of the planarelement base portion to an opposite second major face thereof Variationsof the sixteenth embodiments may be provided to form additionalsixteenth embodiments that include third of the fluid circuit elementsthat include at least one column-shaped channel with electrodes on aside thereof, where the electrodes are positioned in the planar elementbase portion and extend between a first major face of the planar elementbase portion to an opposite second major face thereof. Variations of thesixteenth embodiments may be provided to form additional sixteenthembodiments that include third of the fluid circuit elements thatinclude at least one column-shaped channel with electrodes on a sidethereof, where the electrodes are positioned in the planar element baseportion and extend between a first major face of the planar element baseportion to an opposite second major face thereof. Variations of thesixteenth embodiments may be provided to form additional sixteenthembodiments in which the column-shaped channel defines a recess has anaccess and blind end spaced apart along an axis of the column-shapedpart recess that is parallel with a major plane of the planar elementbase portion, the junction part recess axis and the column shaped partrecess axis is parallel to permit a single action to form both duringmolding.

Variations of the sixteenth embodiments may be provided to formadditional sixteenth embodiments in which the column-shaped part recessaccess is closed with an end plate. Variations of the sixteenthembodiments may be provided to form additional sixteenth embodiments inwhich the column-shaped channel defines a recess has an access and blindend spaced apart along an axis of the column-shaped part recess that isparallel with a major plane of the planar element base portion, thejunction part recess axis and the column shaped part recess axis isparallel to permit a single action to form both during molding.Variations of the sixteenth embodiments may be provided to formadditional sixteenth embodiments in which the column-shaped part recessaccess is closed with an end plate. Variations of the sixteenthembodiments may be provided to form additional sixteenth embodiments inwhich the planar element has an opening to form a fluid communicationchannel between each column-shaped channel recess and a region of thetrough shaped channels. Variations of the sixteenth embodiments may beprovided to form additional sixteenth embodiments in which the wallelements coincide with a single plane. Variations of the sixteenthembodiments may be provided to form additional sixteenth embodiments inwhich the trough shaped channels and the first fluid circuit elementsare located on a first major face of the planar element base portionthat is opposite a second major face, the second fluid circuit elementsis attached to the second major face.

According to seventeenth embodiments, the disclosed subject matterincludes a medicament proportioning system. A medicament proportioningmodule has a pump with a pumping actuator or a pinch-clamp actuator, andat least one temperature or pressure sensor. A disposable fluid circuithas a generally planar element has a base portion and wall elementsformed thereon, the wall elements defining trough-shaped channels whichare sealed by a film sealingly attached to the edges of the wallsopposite an edge of each wall that attaches to the base element toenclose the trough shaped channels. The trough shaped channels includeelongate portions that interconnect fluid circuit elements. Themedicament proportioning module has one or both of a temperature andpressure sensor. First of the fluid circuit elements include widenedportions of the trough shaped channels that are positioned on the baseportion to engage the one or both of the at least one temperature orpressure sensor of the medicament proportioning module. Second of thefluid circuit elements include at least one pumping tube segment or atleast one pinch-clamping actuator of the medicament proportioning modulethat engages with a pumping actuator or pinch-clamping actuator of themedicament proportioning module. The second of the fluid circuitelements interface with a junction part defining a recess has an accessand blind end spaced apart along an axis of the junction part recessthat is parallel with a major plane of the planar element base portion.An opening is formed in the planar element to form a fluid communicationchannel between each junction part recess and a region of the troughshaped channels.

Variations of the seventeenth embodiments may be provided to formadditional seventeenth embodiments in which the second of the fluidcircuit elements has a tubular portion inserted in the junction partrecess, and the tubular portion has a longitudinal axis collinear withthe recess axis. Variations of the seventeenth embodiments may beprovided to form additional seventeenth embodiments in which the secondof the fluid circuit elements include at least one pumping tube segmentthat engages with a pinch-clamping actuator of the medicamentproportioning module. Variations of the seventeenth embodiments may beprovided to form additional seventeenth embodiments in which the troughshaped channels and the first fluid circuit elements are located on afirst major face of the planar element base portion that is opposite asecond major face, the second fluid circuit elements is attached to thesecond major face. Variations of the seventeenth embodiments may beprovided to form additional seventeenth embodiments in which the troughshaped channels and the first fluid circuit elements are located on afirst major face of the planar element base portion that is opposite asecond major face, the second fluid circuit elements is attached to thesecond major face.

Variations of the seventeenth embodiments may be provided to formadditional seventeenth embodiments that include third of the fluidcircuit elements that include at least one column-shaped channel withelectrodes on a side thereof, where the electrodes are positioned in theplanar element base portion and extend between a first major face of theplanar element base portion to an opposite second major face thereof,the medicament proportioning module has electrical contacts facing thefirst major face and positioned to contact the electrodes. Variations ofthe seventeenth embodiments may be provided to form additionalseventeenth embodiments in which the trough shaped channels and thefirst fluid circuit elements are located on the first major face of theplanar element base portion and the second and third fluid circuitelements are attached to the second major face. Variations of theseventeenth embodiments may be provided to form additional seventeenthembodiments in which the column-shaped channel defines a recess has anaccess and blind end spaced apart along an axis of the column-shapedpart recess that is parallel with a major plane of the planar elementbase portion. Variations of the seventeenth embodiments may be providedto form additional seventeenth embodiments in which the column-shapedpart recess access is closed with an end plate. Variations of theseventeenth embodiments may be provided to form additional seventeenthembodiments in which the column-shaped channel defines a recess has anaccess and blind end spaced apart along an axis of the column-shapedpart recess that is parallel with a major plane of the planar elementbase portion. Variations of the seventeenth embodiments may be providedto form additional seventeenth embodiments in which the column-shapedpart recess access is closed with an end plate. T

Variations of the seventeenth embodiments may be provided to formadditional seventeenth embodiments in which the planar element has anopening to form a fluid communication channel between each column-shapedchannel recess and a region of the trough shaped channels. Variations ofthe seventeenth embodiments may be provided to form additionalseventeenth embodiments in which the medicament proportioning module hasa pumping actuator and the second of the fluid circuit elements includeat least one pumping tube segment that engages with the pumping actuatorof the medicament proportioning module, wherein the trough shapedchannels and the first fluid circuit elements are located on a firstmajor face of the planar element base portion that is opposite a secondmajor face, the second fluid circuit elements is attached to the secondmajor face, and the planar element has openings to permit actuators ofthe medicament proportioning module to reach from the first side to thesecond side to engage the at least one pumping tube segment. Variationsof the seventeenth embodiments may be provided to form additionalseventeenth embodiments in which the medicament proportioning module hasa pinch clamp actuator and the second of the fluid circuit elementsinclude at least one pinch tube segment that engages with the pinchclamp actuator of the medicament proportioning module, wherein thetrough shaped channels and the first fluid circuit elements are locatedon a first major face of the planar element base portion that isopposite a second major face, the second fluid circuit elements isattached to the second major face, and the planar element has openingsto permit actuators of the medicament proportioning module to reach fromthe first side to the second side to engage the at least one pinch tubesegment.

Variations of the seventeenth embodiments may be provided to formadditional seventeenth embodiments in which the medicament proportioningmodule has a pumping actuator and the second of the fluid circuitelements include at least one pumping tube segment that engages with thepumping actuator of the medicament proportioning module, wherein thetrough shaped channels and the first fluid circuit elements are locatedon a first major face of the planar element base portion that isopposite a second major face, the second fluid circuit elements isattached to the second major face, and the planar element has openingsto permit actuators of the medicament proportioning module to reach fromthe first side to the second side to engage the at least one pumpingtube segment. Variations of the seventeenth embodiments may be providedto form additional seventeenth embodiments in which the medicamentproportioning module has a pinching actuator and the second of the fluidcircuit elements include at least one pinch tube segment that engageswith the pinch clamp actuator of the medicament proportioning module,wherein the trough shaped channels and the first fluid circuit elementsare located on a first major face of the planar element base portionthat is opposite a second major face, the second fluid circuit elementsis attached to the second major face, and the planar element hasopenings to permit actuators of the medicament proportioning module toreach from the first side to the second side to engage the at least onepinch tube segment. Variations of the seventeenth embodiments may beprovided to form additional seventeenth embodiments that include thirdof the fluid circuit elements that include at least one column-shapedchannel with electrodes on a side thereof, where the electrodes arepositioned in the planar element base portion and extend between a firstmajor face of the planar element base portion to an opposite secondmajor face thereof. The system of claim 184, further comprising third ofthe fluid circuit elements that include at least one column-shapedchannel with electrodes on a side thereof, where the electrodes arepositioned in the planar element base portion and extend between a firstmajor face of the planar element base portion to an opposite secondmajor face thereof, the medicament proportioning module has aconductivity detection circuit with contacts positioned to makeelectrical contact with the electrodes.

Variations of the seventeenth embodiments may be provided to formadditional seventeenth embodiments that include third of the fluidcircuit elements that include at least one column-shaped channel withelectrodes on a side thereof, where the electrodes are positioned in theplanar element base portion and extend between a first major face of theplanar element base portion to an opposite second major face thereof,the medicament proportioning module has a conductivity detection circuitwith contacts positioned to make electrical contact with the electrodes.The system of claim 186, further comprising third of the fluid circuitelements that include at least one column-shaped channel with electrodeson a side thereof, where the electrodes are positioned in the planarelement base portion and extend between a first major face of the planarelement base portion to an opposite second major face thereof, themedicament proportioning module has a conductivity detection circuitwith contacts positioned to make electrical contact with the electrodes.Variations of the seventeenth embodiments may be provided to formadditional seventeenth embodiments in which the column-shaped channeldefines a recess has an access and blind end spaced apart along an axisof the column-shaped part recess that is parallel with a major plane ofthe planar element base portion, the junction part recess axis and thecolumn shaped part recess axis is parallel to permit a single action toform both during molding. Variations of the seventeenth embodiments maybe provided to form additional seventeenth embodiments in which thecolumn-shaped part recess access is closed with an end plate.

Variations of the seventeenth embodiments may be provided to formadditional seventeenth embodiments in which the column-shaped channeldefines a recess has an access and blind end spaced apart along an axisof the column-shaped part recess that is parallel with a major plane ofthe planar element base portion, the junction part recess axis and thecolumn shaped part recess axis is parallel to permit a single action toform both during molding. Variations of the seventeenth embodiments maybe provided to form additional seventeenth embodiments in which thecolumn-shaped part recess access is closed with an end plate. Variationsof the seventeenth embodiments may be provided to form additionalseventeenth embodiments in which the planar element has an opening toform a fluid communication channel between each column-shaped channelrecess and a region of the trough shaped channels. Variations of theseventeenth embodiments may be provided to form additional seventeenthembodiments in which the medicament proportioning module has a datareader and the planar element base portion has a data carrier readableby the data reader. Variations of the seventeenth embodiments may beprovided to form additional seventeenth embodiments in which the datacarrier is attached to the first major face and the data reader ispositioned on the medicament proportioning module on a side of the firstside of the planar element base portion toward which the first majorface faces. Variations of the seventeenth embodiments may be provided toform additional seventeenth embodiments in which the wall elementscoincide with a single plane. Variations of the seventeenth embodimentsmay be provided to form additional seventeenth embodiments in which thetrough shaped channels and the first fluid circuit elements are locatedon a first major face of the planar element base portion that isopposite a second major face, the second fluid circuit elements isattached to the second major face.

According to eighteenth embodiments, the disclosed subject matterincludes a medicament proportioning system with a water purificationmodule that has a tap water inlet, deionization filters, and a purifiedwater outlet. A medicament proportioning module is connected to receivewater from the purified water outlet, and the medicament proportioningmodule is interoperable with a replaceable medicament fluid circuit byengaging sensors, actuators, and a controller incorporated therein. Thereplaceable medicament fluid circuit is a replaceable unit with at leastone inlet and two outlets, and includes: (1) a water inlet for water,(2) a medicament outlet for product medicament output, and (3) a wasteoutlet for waste fluid. The replaceable medicament fluid circuit has,permanently attached thereto, at least one concentrate container filledwith medicament concentrate and is entirely sealed from an externalenvironment such that the at least one inlet is the exclusive mechanismfor admission of fluid into the replaceable medicament fluid circuit.The at least one inlet has a sterile filter to block the movement of anycontaminants from entering the replaceable medicament fluid circuit dueto the making of the connection between the water outlet and the waterinlet or otherwise. The replaceable medicament fluid circuit has aninterior volume that is sterile with the at least one inlet and outletsis openably sealed, whereby the replaceable medicament fluid circuit maybe provided as a sterile unit with a minimum of connections to be made.

Variations of the eighteenth embodiments may be provided to formadditional eighteenth embodiments in which the replaceable medicamentfluid circuit has water pumping tube segment connected to convey waterfrom the water inlet toward the medicament outlet, and at least onemedicament pumping tube segment connected to convey the at least onemedicament into a product fluid channel connecting the water inlet tothe medicament outlet. Variations of the eighteenth embodiments may beprovided to form additional eighteenth embodiments in which themedicament proportioning module has a water pump actuator shaped andpositioned to pump water through the water pumping tube segment at leastone medicament pump actuator shaped and positioned to pump medicamentthrough the medicament pumping tube segment, wherein the at least onemedicament pumping tube segment connects the at least one medicamentconcentrate container to the product fluid channel. Variations of theeighteenth embodiments may be provided to form additional eighteenthembodiments in which the at least one inlet and two outlets all includea respective sterile filter. Variations of the eighteenth embodimentsmay be provided to form additional eighteenth embodiments in which theat least two outlets include a check valve.

Variations of the eighteenth embodiments may be provided to formadditional eighteenth embodiments in which the replaceable medicamentfluid circuit has a self-supporting container containing the at leastone concentrate container connected by tubes to a cartridge, thecartridge has the sensor and actuator portions of the medicament fluidcircuit that engage with the sensors and actuators of the medicamentproportioning module. Variations of the eighteenth embodiments may beprovided to form additional eighteenth embodiments in which thecartridge has a data carrier that transmits data to the controller.Variations of the eighteenth embodiments may be provided to formadditional eighteenth embodiments in which the data carrier containsdata that indicates the composition of the medicament concentrate in theat least one concentrate container. Variations of the eighteenthembodiments may be provided to form additional eighteenth embodiments inwhich the at least one concentrate container includes a concentratecontainer with a dry solute has a diluent water inlet, and the cartridgehas a pinch valve segment for controlling water flow from the waterinlet to the diluent water inlet. Variations of the eighteenthembodiments may be provided to form additional eighteenth embodiments inwhich the controller is programmed to regulate flow to the diluent waterinlet responsively to a demand for medicament from a device connected tothe medicament outlet.

According to nineteenth embodiments, the disclosed subject matterincludes a medicament proportioning system with a water purificationmodule that has a tap water inlet and a purified water outlet. Thesystem has deionization filters positioned between the tap water inletand purified water outlet to purify water. A medicament proportioningmodule is connected to receive water from the purified water outlet, andthe medicament proportioning module is interoperable with a replaceablemedicament fluid circuit. The medicament proportioning module has amedicament proportioning fluid circuit with a concentrate pump sectionand a water pump section that engage respective pump actuators totransfer purified water and concentrate to a medicament supply channelof the medicament proportioning fluid circuit, the medicament supplychannel has a product medicament outlet that is connected to supply amixture of the water and concentrates transferred to the medicamentsupply channel. The medicament supply channel includes an accumulatorwith an internal volume whose size is selected to be no more than twicea volume predetermined to be necessary to permit the respective pumpactuators to operate a constant speed without starving flow to apredefined consuming device connectable to the product medicamentoutlet, where the predefined consuming device draws medicament atvariable rate.

According to twentieth embodiments, the disclosed subject matterincludes a medicament proportioning system with a water purificationmodule, a tap water inlet, and a purified water outlet. Deionizationfilters are positioned between the tap water inlet and purified wateroutlet to purify water. A medicament proportioning module is connectedto receive water from the purified water outlet, and the medicamentproportioning module is interoperable with a replaceable medicamentfluid circuit. The medicament proportioning module has a medicamentproportioning fluid circuit with a concentrate pump section and a waterpump section that engage respective pump actuators to transfer purifiedwater and concentrate to a medicament supply channel of the medicamentproportioning fluid circuit. The medicament supply channel has a productmedicament outlet that is connected to supply a mixture of the water andconcentrates transferred to the medicament supply channel. Themedicament supply channel includes an accumulator with rigid buttonportion supporting, in an expansion direction of expansion andcontraction of an internal volume of the accumulator, an elastic web andis supported by the elastic web in one or more directions or momentsother than the expansion direction. The rigid button is urged by anurging element positioned and oriented to resist the expansion theaccumulator internal volume. The rigid button makes no friction-causingsliding engagement with other portions of the accumulator. As a result,a pressure-volume characteristic of the accumulator internal volume isdetermined by the urging element.

According to twenty-first embodiments, the disclosed subject matterincludes a medicament proportioning system that has a water purificationmodule with a tap water inlet and a purified water outlet. Deionizationfilters are positioned between the tap water inlet and purified wateroutlet to purify water. A medicament proportioning module is connectedto receive water from the purified water outlet, and the medicamentproportioning module is interoperable with a replaceable medicamentfluid circuit. The medicament proportioning module has a medicamentproportioning fluid circuit with a concentrate pump section and a waterpump section that engage respective pump actuators to transfer purifiedwater and concentrate to a medicament supply channel of the medicamentproportioning fluid circuit. The medicament supply channel has a productmedicament outlet that is connected to supply a mixture of the water andconcentrates transferred to the medicament supply channel. The productmedicament outlet is connectable to a predefined medicament consumingdevice that draws medicament at a periodic non-uniform rate of flow. Themedicament supply channel includes an accumulator that has a variableinternal volume that includes an urging element that provides aprogressive pressure-volume characteristic thereof. A pressuretransducer is arranged in the medicament supply channel to output apressure signal indicative of a pressure in the accumulator internalvolume, a controller that controls the pump actuators responsively tothe pressure signal to operate the pump actuators at a rate that lacks aperiodicity of the periodic non-uniform rate of flow.

Variations of the nineteenth and twentieth embodiments may be providedto form additional nineteenth and twentieth embodiments in which theproduct medicament outlet is connected to a predefined medicamentconsuming device. Variations of the nineteenth and twentieth embodimentsmay be provided to form additional nineteenth and twentieth embodimentsin which the consuming device is a blood treatment system. Variations ofthe nineteenth and twentieth embodiments may be provided to formadditional nineteenth and twentieth embodiments in which the consumingdevice is a hemodialysis system. Variations of the nineteenth andtwentieth embodiments may be provided to form additional nineteenth andtwentieth embodiments in which the consuming device is a volumetricbalancing component of a blood treatment system. Variations of thetwenty-first embodiments may be provided to form additional twenty-firstembodiments in which the product medicament outlet is connected to apredefined medicament consuming device. Variations of the twenty-firstembodiments may be provided to form additional twenty-first embodimentsin which the consuming device is a blood treatment system. Variations ofthe twenty-first embodiments may be provided to form additionaltwenty-first embodiments in which the consuming device is a hemodialysissystem. Variations of the twenty-first embodiments may be provided toform additional twenty-first embodiments in which the consuming deviceis a volumetric balancing component of a blood treatment system.

According to twenty-second embodiments, the disclosed subject matterincludes a blood treatment system with a water purification module thathas a product water outlet. A medicament proportioning module isconnected to receive product water through the product water outlet andhas pumps for concentrate and water that are controlled to mix productmedicament and convey it through a product medicament channel, connectedto a product medicament outlet. A blood treatment module is connected tothe product medicament outlet, and the blood treatment module has a pumpto draw product medicament from the product medicament outlet. Themedicament proportioning module pumps at rate that is responsive to amechanical signal generated by the blood treatment module, whereby flowbetween the medicament proportioning module and the blood processingmodule may be governed without the need for electrical control signals.

Variations of the twenty-second embodiments may be provided to formadditional twenty-second embodiments in which the product medicamentchannel includes an accumulator with an expandable interior volume.Variations of the twenty-second embodiments may be provided to formadditional twenty-second embodiments in which the accumulator is atleast partly integrated in a replaceable cartridge. Variations of thetwenty-second embodiments may be provided to form additionaltwenty-second embodiments in which the accumulator has a spring that isbiased against expansion of an interior volume thereof. Variations ofthe twenty-second embodiments may be provided to form additionaltwenty-second embodiments in which the blood processing module includesa volumetric balancing system that draws medicament from the productmedicament outlet at an unsteady rate that has a periodic component thatis smoothed or canceled by the accumulator, such that rates of flow ofthe medicament proportioning module pumps responsive to the periodiccomponent is diminished. Variations of the twenty-second embodiments maybe provided to form additional twenty-second embodiments in which theblood processing module includes a volumetric balancing system thatdraws medicament from the product medicament outlet at an unsteady ratethat has a periodic component that is canceled by the accumulator, suchthat rates of flow of the medicament proportioning module pumpsresponsive to the periodic component is eliminated.

According to twenty-third embodiments, the disclosed subject matterincludes a medicament supply system with a water purification modulethat has a product water outlet. A medicament proportioning module isconnected to receive product water through the product water outlet andhas pumps for concentrate and water that are controlled to mix productmedicament and convey it through a product medicament channel, connectedto a product medicament outlet. The medicament proportioning modulepumps at rate controlled to maintain a target average pressure at theproduct medicament outlet such that an attached medicament consumingdevice can draw fluid at a current pressure at the product medicamentoutlet on-demand. The medicament proportioning module has an accumulatorupstream of the product medicament outlet to permit irregular orperiodic draw of medicament therefrom without a need for a concomitantirregular or periodic change in the pumping rate of the medicamentproportioning module pumps.

Variations of the twenty-third embodiments may be provided to formadditional twenty-third embodiments in which the product medicamentchannel includes an accumulator with an expandable interior volume.Variations of the twenty-third embodiments may be provided to formadditional twenty-third embodiments in which the accumulator is at leastpartly integrated in a replaceable cartridge. Variations of thetwenty-third embodiments may be provided to form additional twenty-thirdembodiments in which the accumulator has a spring that is biased againstexpansion of an interior volume thereof. Variations of the twenty-thirdembodiments may be provided to form additional twenty-third embodimentsin which the blood processing module includes a volumetric balancingsystem that draws medicament from the product medicament outlet at anunsteady rate that has a periodic component that is smoothed or canceledby the accumulator, such that rates of flow of the medicamentproportioning module pumps responsive to the periodic component isdiminished. Variations of the twenty-third embodiments may be providedto form additional twenty-third embodiments in which the bloodprocessing module includes a volumetric balancing system that drawsmedicament from the product medicament outlet at an unsteady rate thathas a periodic component that is canceled by the accumulator, such thatrates of flow of the medicament proportioning module pumps responsive tothe periodic component is eliminated.

According to twenty-fourth embodiments, the disclosed subject matterincludes a blood treatment system. A water purification module has aproduct water outlet. A medicament proportioning module is connected toreceive product water through the product water outlet and has pumps forconcentrate and water that are controlled to mix product medicament andconvey it through a product medicament channel, connected to a productmedicament outlet. A blood treatment module, separately housed from thewater purification and medicament proportioning modules, is connected tothe product medicament outlet, and the blood treatment module has a pumpto draw product medicament from the product medicament outlet. The bloodtreatment module has a self-contained replaceable fluid circuit forreceiving product medicament from the medicament proportioning moduleand conveying through a blood treatment device thereby generating wastemedicament, the replaceable fluid circuit is connected directly to adrain outlet for disposal of waste medicament without the wastemedicament passing through the medicament proportioning module.

Variations of the twenty-fourth embodiments may be provided to formadditional twenty-fourth embodiments in which the product medicamentchannel includes an accumulator with an expandable interior volume.Variations of the twenty-fourth embodiments may be provided to formadditional twenty-fourth embodiments in which the accumulator is atleast partly integrated in a replaceable cartridge. Variations of thetwenty-fourth embodiments may be provided to form additionaltwenty-fourth embodiments in which the accumulator has a spring that isbiased against expansion of an interior volume thereof. Variations ofthe twenty-fourth embodiments may be provided to form additionaltwenty-fourth embodiments in which the blood processing module includesa volumetric balancing system that draws medicament from the productmedicament outlet at an unsteady rate that has a periodic component thatis smoothed or canceled by the accumulator, such that rates of flow ofthe medicament proportioning module pumps responsive to the periodiccomponent is diminished. Variations of the twenty-fourth embodiments maybe provided to form additional twenty-fourth embodiments in which theblood processing module includes a volumetric balancing system thatdraws medicament from the product medicament outlet at an unsteady ratethat has a periodic component that is canceled by the accumulator, suchthat rates of flow of the medicament proportioning module pumpsresponsive to the periodic component is eliminated.

According to twenty-fifth embodiments, the disclosed subject matterincludes a medicament preparation system with a medicament generationsystem that has actuators and sensors positioned and shaped to interfacea fluid circuit. The fluid circuit includes: (1) a first containercontaining a first concentrate connected for flow communication, througha first pumping tube segment, to a medicament supply line with anoutlet, (2) a second container containing a second concentrate connectedfor flow communication, through a second pumping tube segment, to themedicament supply line, and (3) a water inlet line of the medicamentsupply line connected for flow communication, through a third pumpingtube segment, to the medicament supply line. A sterile filter in thewater inlet line is positioned to filter water entering the medicamentsupply line. The fluid circuit is a disposable replaceable componentthat is sterile and sealed from the external environment. The fluidcircuit includes a first concentration measurement station positioned inthe medicament supply line to measure a concentration of water mixedwith the first concentrate. The fluid circuit includes a secondconcentration measurement station positioned in the medicament supplyline to measure a concentration of water mixed with both the firstconcentrate and the second concentrate.

Variations of the twenty-fifth embodiments may be provided to formadditional twenty-fifth embodiments in which the second concentrationmeasurement station is positioned in the medicament supply linedownstream of the first concentration measurement station. Variations ofthe twenty-fifth embodiments may be provided to form additionaltwenty-fifth embodiments in which the first and second concentrationmeasurement stations each includes a temperature and conductivitysensor. Variations of the twenty-fifth embodiments may be provided toform additional twenty-fifth embodiments in which the first and secondconcentration measurement stations each includes two temperature sensorsand two conductivity sensors. Variations of the twenty-fifth embodimentsmay be provided to form additional twenty-fifth embodiments that includea controller programmed to calculate, for each of the first and secondconcentration measurement stations, redundant concentration measurementsbased on the two temperature and the two conductivity sensors output ofthe each of the first and second concentration measurement stations andto generate an error output in response to a predetermined differencethe redundant concentration measurements. Variations of the twenty-fifthembodiments may be provided to form additional twenty-fifth embodimentsin which the first, second, and third pumping tube segments aresupported by a circuit cartridge which orients, aligns, and exposes foraccess the first, second, and third pumping tube segments withrespective actuators of a predefined medicament preparation device.Variations of the twenty-fifth embodiments may be provided to formadditional twenty-fifth embodiments in which the circuit cartridgeincludes a fluid accumulator fluidly coupled between the water inletline and the medicament supply line outlet end that includes apressure-regulating urging element that biases a flexible wall of theaccumulator such that transient changes of fluid pressure therein causeexpansion of the volume of the accumulator.

Variations of the twenty-fifth embodiments may be provided to formadditional twenty-fifth embodiments in which the fluid circuit ispackaged with a box such that the circuit cartridge can be detached orremoved from the box while leaving the first and second containerstherein with lengths of connecting lines between the circuit cartridgeand the box, thereby permitting the circuit cartridge to be installed ina position remote form a position where the box is installed. Variationsof the twenty-fifth embodiments may be provided to form additionaltwenty-fifth embodiments in which the fluid circuit is packaged within abox such that the circuit cartridge can be removed from the box whileleaving the first and second containers therein with lengths ofconnecting lines between the circuit cartridge and the box, therebypermitting the circuit cartridge to be installed in a position remoteform a position where the box is installed. Variations of thetwenty-fifth embodiments may be provided to form additional twenty-fifthembodiments in which the fluid circuit is attached to a box in such away that the circuit cartridge can be detached from the box whileleaving the first and second containers therein with lengths ofconnecting lines between the circuit cartridge and the box, therebypermitting the circuit cartridge to be installed in a position remoteform a position where the box is installed. Variations of thetwenty-fifth embodiments may be provided to form additional twenty-fifthembodiments in which the temperature sensor portion includes a flowchamber with a flat surface to permit a temperature sensor to be placedagainst the flat surface of a predefined sensor of the predefinedmedicament preparation device.

According to twenty-sixth embodiments, the disclosed subject matterincludes a method for supplying medicament to a blood processing system.The method includes filtering water to increase a resistivity thereof toa level of at least 1 megohm-cm to generate high resistivity productwater. The method further includes electrically heating the waterresulting from the filtering includes continuously regulating atemperature thereof to maintain to a temperature calculated to maintainthe body temperature of a patient receiving a blood treatment, theelectrically heating occurring over a course of the blood treatment. Themethod further includes adding medicament concentrate to water resultingfrom the electrically heating. The electrically heating generates avoltage difference between a patient and a heater used for theelectrically heating. The method further includes dropping the voltageover a channel of high resistivity water product water whose dimensionsare effective to reduce current through the channel to less than 50microamperes and adding medicament concentrate to the high resistivityproduct water to generate a product medicament and fluidly andelectrically interfacing the product medicament with a patient bloodcircuit connected to a patient undergoing a blood treatment.

Variations of the twenty-sixth embodiments may be provided to formadditional twenty-sixth embodiments in which the electrically heatingincludes pulse-width modulating an electrical heater. Variations of thetwenty-sixth embodiments may be provided to form additional twenty-sixthembodiments in which the generating a voltage difference includescapacitively coupling a conducting circuit with fluid, in a fluidchannel, that is fluidly coupled to the product medicament. Variationsof the twenty-sixth embodiments may be provided to form additionaltwenty-sixth embodiments in which the filtering includes deionizing tapwater in a deionization filter bed. Variations of the twenty-sixthembodiments may be provided to form additional twenty-sixth embodimentsin which the filtering water increases a resistivity thereof to a levelof at least 3 megohm-cm. Variations of the twenty-sixth embodiments maybe provided to form additional twenty-sixth embodiments in which thefiltering water increases a resistivity thereof to a level of at least 5megohm-cm. Variations of the twenty-sixth embodiments may be provided toform additional twenty-sixth embodiments in which the filtering waterincreases a resistivity thereof to a level of at least 10 megohm-cm.

Variations of the twenty-sixth embodiments may be provided to formadditional twenty-sixth embodiments in which the electrically heatingplaces the high resistivity water in direct contact with a permanentelectrical heater which is not replaced between uses, the electricallyheating is followed by sterile-filtering the high resistivity productwater. Variations of the twenty-sixth embodiments may be provided toform additional twenty-sixth embodiments in which the adding medicamentincludes proportioning the high resistivity water with medicamentconcentrate using feedback control with a control target of a measuredpredefined conductivity. Variations of the twenty-sixth embodiments maybe provided to form additional twenty-sixth embodiments in which theadding medicament includes proportioning the high resistivity water withmedicament concentrate through a fluid circuit that is 100% disposable.

According to twenty-seventh embodiments, the disclosed subject matterincludes a system for providing medicament. A sterile circuit withmultiple fluid circuits is interconnected to permit two or morecomponent fluids to be combined to form a product medicament, themultiple fluid circuits has respective inlets for each of the two ormore component fluids and a common outlet, the common outlet is fluidlyconnected by the sterile circuit to the respective inlets to provide acombined medicament product. The sterile circuit defines a sterilebarrier such that internal fluid compartment defined by the multiplefluid circuits is isolated from an external environment, includes therespective inlets. Variations of the twenty-seventh embodiments may beprovided to form additional twenty-seventh embodiments in which thesterile circuit includes pumping portions.

Variations of the twenty-seventh embodiments may be provided to formadditional twenty-seventh embodiments in which the sterile barrierincludes a sterilizing filter positioned at at least one of therespective inlets and has a pore size sufficiently small to filter andsterilize a respective one of the component fluids that may flowtherethrough Variations of the twenty-seventh embodiments may beprovided to form additional twenty-seventh embodiments in which themultiple fluid circuits include a respective pumping tube segment foreach of the component fluids, each is joined to the common outlet.Variations of the twenty-seventh embodiments may be provided to formadditional twenty-seventh embodiments that include a water purificationplant connected to the sterile circuit to deliver water, the water isone of the two or more component fluids, the water purification plant isconnected through one of the respective inlets, the one of therespective inlets has a sterilizing filter with a pore size sufficientlysmall to filter and sterilize water flowing into the sterile circuitthrough the one of the respective inlets. Variations of thetwenty-seventh embodiments may be provided to form additionaltwenty-seventh embodiments that include a controller the controller isadapted to receive prior use data indicating a period of time since themultiple fluid circuits' interior volumes were first wetted and tooutput a command signal indicating whether the sterile circuit is safeto use. Variations of the twenty-seventh embodiments may be provided toform additional twenty-seventh embodiments that include a data reader,connected to the controller, that sends status data to the controller,the status data is derived at least in part on data from stored dataread by the data reader from a data store attached to the sterilecircuit. Variations of the twenty-seventh embodiments may be provided toform additional twenty-seventh embodiments in which the stored dataindicates a type of the sterile circuit. Variations of thetwenty-seventh embodiments may be provided to form additionaltwenty-seventh embodiments in which the stored data indicates a date andtime when the sterile circuit was first wetted. Variations of thetwenty-seventh embodiments may be provided to form additionaltwenty-seventh embodiments that include a treatment device connected tothe common outlet and is of a type that requires a sterile medicament.Variations of the twenty-seventh embodiments may be provided to formadditional twenty-seventh embodiments in which the treatment deviceincludes a blood processing treatment device. Variations of thetwenty-seventh embodiments may be provided to form additionaltwenty-seventh embodiments in which the treatment device includes anextracorporeal blood treatment device. Variations of the twenty-seventhembodiments may be provided to form additional twenty-seventhembodiments in which the sterile circuit internal fluid compartment issterile as a result of the sterile circuit is a product of manufacturethat includes sealing a disposable unit and sterilizing it. Variationsof the twenty-seventh embodiments may be provided to form additionaltwenty-seventh embodiments in which the sterile circuit internal fluidcompartment is sterile as a result of the sterile circuit is sterilizedand used for a limited time to prevent colonization of bacteria.Variations of the twenty-seventh embodiments may be provided to formadditional twenty-seventh embodiments in which the sterile circuitinternal fluid compartment is sterile as a result of the sterile circuitis a sterile disposable. Variations of the twenty-seventh embodimentsmay be provided to form additional twenty-seventh embodiments in whichthe sterile circuit internal fluid compartment is sterile as a result ofa sterilization process. Variations of the twenty-seventh embodimentsmay be provided to form additional twenty-seventh embodiments in whichthe sterile circuit includes sensor and pumping portions positioned andoriented to engage with a predefined medicament preparation module thatcontrols the flow of fluid therethrough.

According to twenty-eighth embodiments, the disclosed subject matterincludes a system for providing a continuous flow of medicament to ablood treatment system. A sterile circuit defines an internal fluidcompartment that is sterile. And sterility maintenance mechanisms forproviding medicament to a blood treatment system while maintaining asterile condition of the internal fluid compartment. The sterilitymaintenance mechanism includes a sterile barrier that prevents ingressof contaminants into the internal fluid compartment. The sterile barrierincludes impermeable walls defining the internal fluid compartment. Atleast one sterile filter blocks contaminants from any incoming fluidflowing into the internal fluid compartment from transferring acontaminant thereinto. A control mechanism permits the use of thesterile circuit for supplying medicament to a blood treatment systemover multiple treatments and limits the number of times or time betweenuses of the sterile circuit for supplying medicament to a bloodtreatment system.

Variations of the twenty-eighth embodiments may be provided to formadditional twenty-eighth embodiments in which the sterile circuit hasinlets for two or more fluids that are interconnected to fluidly connectto a common outlet for the supply of medicament, such that the two ormore fluids may be mixed thereby. Variations of the twenty-eighthembodiments may be provided to form additional twenty-eighth embodimentsin which the control mechanism is responsive to sterility-enforcementdata indicating a time since the sterile circuit was first used forpreparing medicament, a volume of fluid processed by the sterilecircuit, a date of manufacture, a lot number, or a type of the sterilecircuit. Variations of the twenty-eighth embodiments may be provided toform additional twenty-eighth embodiments in which thesterility-enforcement data is stored on a data carrier attached to thesterile circuit.

According to twenty-ninth embodiments, the disclosed subject matterincludes a method of performing an extracorporeal blood treatment. Themethod includes, at a first time, flowing component fluids to form amedicament into a sterile compartment, the flowing includes wetting thesterile compartment. The method further includes mixing the componentfluids to form a medicament and supplying the same, at the first time,to a medical treatment apparatus for providing a medical treatment. Themethod further includes, at a second time, with a controller andresponsively to use-permission data, permitting or preventing a furtherflowing component fluids to form a medicament into the sterilecompartment. The method further includes at the second time, uponinitially preventing the further flowing, permitting a further flowingcomponent fluids to form a medicament into the same or a new sterilecompartment after a replacement or sterilization of the sterilecompartment so as to ensure sterility thereof, the permitting includesverifying that the sterile compartment has been replaced or sterilized.The use-permission data is indicative of a time since the sterilecompartment was first wetted for preparing medicament, a volume of fluidprocessed by the sterile compartment, a date of manufacture of thesterile compartment, a lot number of the sterile compartment, or a typeof the sterile compartment.

Variations of the twenty-ninth embodiments may be provided to formadditional twenty-ninth embodiments that include measuring aconductivity and temperature of a mixture resulting from the mixing.

According to thirtieth embodiments, the disclosed subject matterincludes a system for inline medicament mixing, comprising: a waterpurification plant connected at a tap water inlet thereof to water mainssupply providing tap water. An air break is connected to receive waterfrom the tap water inlet under control of a control valve connected to acontroller. The air break includes an air break chamber with at leastone level sensor, the controller controlling the control valve tomaintain a predefined water level or range of water levels within theair break chamber. The air break chamber has an overflow outlet thatpermits water to flow out of the air break chamber if a pressure orwater level in the air break chamber exceeds a predetermined magnitude,such that back flow into the tap water inlet is prevented. The waterpurification plant has a preparation pump controlled by the controllerto pump water, on-demand, from the air break chamber and supply filteredwater to a product water outlet and controlled by the controller tomaintain a predefined pressure causing water to flow through filters ofthe water purification plant. A vent in the air break chamber permitsair to flow out of the air break chamber to permit the water level torise in the absence of flow thereinto from the tap water inlet. Amedicament proportioning system, has a water pump, connected to theproduct water outlet, the medicament proportioning system water pumpdrawing water on-demand from the product water outlet.

According to thirty-first embodiments, the disclosed subject matterincludes a system for inline medicament mixing. A water purificationplant is connected at a tap water inlet thereof to water mains supplyproviding tap water. The thirty-first embodiment further includes acontroller and a control valve. An air break is connected to receivewater from the tap water inlet under control of the control valveconnected to the controller. The air break includes an air break chamberwith at least one level sensor, the controller controlling the controlvalve to maintain a predefined water level or range of water levelswithin the air break chamber. The air break chamber has an outlet fromwhich water is drawn from the air break chamber and passed throughfilters to generate product water. The air break chamber has an overflowoutlet that permits water to flow out of the air break chamber if apressure or water level in the air break chamber exceeds a predeterminedmagnitude, such that back flow into the tap water inlet is prevented. Amedicament proportioning portion has a water pump, connected to theproduct water outlet, the medicament proportioning portion water pumpdrawing water on-demand from the product water outlet.

Variations of the thirty-second embodiments may be provided to formadditional thirty-second embodiments in which the controller controlsthe air break water level below a level of the overflow outlet.Variations of the thirty-second embodiments may be provided to formadditional thirty-second embodiments in which the water mains supply isunder a positive pressure. Variations of the thirty-second embodimentsmay be provided to form additional thirty-second embodiments in whichthe medicament proportioning portion water pump operates at a speeddetermined by a medicament demand signal from a treatment device.Variations of the thirty-second embodiments may be provided to formadditional thirty-second embodiments in which the wherein the medicamentproportioning portion water pump operates at a speed determined byvolume drawn therefrom from by a treatment device. Variations of thethirty-second embodiments may be provided to form additionalthirty-second embodiments in which the medicament demand signal ismechanical. Variations of the thirty-second embodiments may be providedto form additional thirty-second embodiments in which the medicamentdemand signal is a pressure signal. Variations of the thirty-secondembodiments may be provided to form additional thirty-second embodimentsin which the medicament demand signal is an electronic data signal.Variations of the thirty-second embodiments may be provided to formadditional thirty-second embodiments that include a water leakagedetector arranged to detect water exiting the air break chamber fromoverflow outlet and the controller.

Further variations of the thirty-second embodiments may be provided toform additional thirty-second embodiments in which the controller is aprogrammable controller programmed to output an error signal when wateris detected by the water leakage detector. Variations of thethirty-second embodiments may be provided to form additionalthirty-second embodiments that include a conductivity sensor in a waterflow path of the air break. Variations of the thirty-second embodimentsmay be provided to form additional thirty-second embodiments thatinclude a conductivity sensor in the air break chamber. Variations ofthe thirty-second embodiments may be provided to form additionalthirty-second embodiments in which the air break chamber is generallycylindrical in shape. Variations of the thirty-second embodiments may beprovided to form additional thirty-second embodiments in which the atleast one level sensor is at least two level sensors each located atrespective positions of the air break chamber. Variations of thethirty-second embodiments may be provided to form additionalthirty-second embodiments in which the at least one level sensor is atleast three level sensors each located at respective positions of theair break chamber. Variations of the thirty-second embodiments may beprovided to form additional thirty-second embodiments in which thecontroller is a programmable controller. Variations of the thirty-secondembodiments may be provided to form additional thirty-second embodimentsthat include an extracorporeal blood treatment system that draws productmedicament from the medicament proportioning portion on-demand, whichdemand the medicament proportioning portion detects and satisfies, andthe medicament proportioning portion draws water from the waterpurification plant on-demand, which the controller satisfies bymaintaining a level of water in the air break chamber. Variations of thethirty-second embodiments may be provided to form additionalthirty-second embodiments in which the medicament proportioning portiondraws water from the water purification plant on-demand, which thecontroller satisfies by maintaining a level of water in the air breakchamber. Variations of the thirty-second embodiments may be provided toform additional thirty-second embodiments in which the air break chamberoutlet supplies water at a pressure determined only by a weight of awater column of water in the air break chamber, whereby pressure fromthe mains, includes fluctuations thereof, are not transmitted downstreamto the filters or the medicament proportioning portion.

According to thirty-third embodiments, the disclosed subject matterincludes a fluid circuit for a predefined medicament preparation systemhaving actuators and sensors that are interoperable with the fluidcircuit. The fluid circuit includes a sterile circuit with multiplefluid circuits interconnected to permit two or more component fluids tobe combined to form a product medicament. The multiple fluid circuitshaving respective inlets for each of said two or more component fluidsand a common outlet, the common outlet being fluidly connected by thesterile circuit to the respective inlets to provide a combinedmedicament product. The sterile circuit defines a sterile barrier suchthat internal fluid compartment defined by said multiple fluid circuitsis isolated from an external environment, including said respectiveinlets. One or more concentration measurement stations include fluidconductivity and temperature measurement portions which are positionedwithin the fluid circuit to detect conductivity and temperature ofmixtures of the two or more component fluids and further positioned,when the sterile circuit is loaded in the predefined medicamentpreparation system, to engage with sensor components thereof to generateconductivity and temperature signals of said mixtures.

Variations of the thirty-third embodiments may be provided to formadditional thirty-third embodiments in which the sterile barrierincludes a sterilizing filter positioned at at least one of saidrespective inlets and having a pore size sufficiently small to filterand sterilize a respective one of said component fluids that may flowtherethrough. Variations of the thirty-third embodiments may be providedto form additional thirty-third embodiments in which the multiple fluidcircuits include a respective pumping tube segment for each of saidcomponent fluids, each being joined to the common outlet. Variations ofthe thirty-third embodiments may be provided to form additionalthirty-third embodiments in which one of said respective inlets includesa water inlet connectable to a water purification plant to deliver wateras one of said two or more component fluids, the one of said respectiveinlets having a sterilizing filter with a pore size sufficiently smallto filter and sterilize water flowing into said sterile circuit throughsaid one of said respective inlets. Variations of the thirty-thirdembodiments may be provided to form additional thirty-third embodimentsthat include a data reader, attached to said sterile circuit, storingdata indicating data indicating at least one characteristic of a usagehistory of said sterile circuit. Variations of the thirty-thirdembodiments may be provided to form additional thirty-third embodimentsthat include a data reader, attached to said sterile circuit, storingdata indicating data indicating a type of said sterile circuit.Variations of the thirty-third embodiments may be provided to formadditional thirty-third embodiments that include a data reader, attachedto said sterile circuit, storing data indicating a first time saidsterile circuit was first wetted. Variations of the thirty-thirdembodiments may be provided to form additional thirty-third embodimentsin which the sterile circuit internal fluid compartment is sterile as aresult of said sterile circuit being a sterile disposable.

According to thirty-fourth embodiments, the disclosed subject matterincludes a system for providing medicament with a sterile circuit withmultiple fluid circuits interconnected to permit two or more componentfluids to be combined to form a product medicament, the multiple fluidcircuits having respective inlets for each of said two or more componentfluids and a common outlet, the common outlet being fluidly connected bythe sterile circuit to the respective inlets to provide a combinedmedicament product. The sterile circuit defines a sterile barrier suchthat internal fluid compartment defined by said multiple fluid circuitsis isolated from an external environment, including said respectiveinlets. The sterile circuit includes one or more concentrationmeasurement stations including fluid conductivity and temperaturemeasurement portions. A controller has sensor components to generateconductivity and temperature signals, the sensor components engagingwith conductivity and temperature measurement portions of the sterilecircuit that are positioned to detect temperature and conductivity ofmixtures of said two or more components.

Variations of the thirty-fourth embodiments may be provided to formadditional thirty-fourth embodiments in which the sterile barrierincludes a sterilizing filter positioned at at least one of saidrespective inlets and having a pore size sufficiently small to filterand sterilize a respective one of said component fluids that may flowtherethrough. Variations of the thirty-fourth embodiments may beprovided to form additional thirty-fourth embodiments in which themultiple fluid circuits include a respective pumping tube segment foreach of said component fluids, each being joined to the common outlet.Variations of the thirty-fourth embodiments may be provided to formadditional thirty-fourth embodiments that include a water purificationplant connected to said sterile circuit to deliver water, said waterbeing one of said two or more component fluids, the water purificationplant being connected through one of said respective inlets, the one ofsaid respective inlets having a sterilizing filter with a pore sizesufficiently small to filter and sterilize water flowing into saidsterile circuit through said one of said respective inlets. Variationsof the thirty-fourth embodiments may be provided to form additionalthirty-fourth embodiments that include a controller the controller beingadapted to receive prior use data indicating a period of time since themultiple fluid circuits interior volumes were first wetted and to outputa command signal indicating whether the sterile circuit is safe to use.Variations of the thirty-fourth embodiments may be provided to formadditional thirty-fourth embodiments that include a data reader,connected to the controller, that sends status data to the controller,the status data being derived at least in part on data from stored dataread by the data reader from a data store attached to the sterilecircuit. Variations of the thirty-fourth embodiments may be provided toform additional thirty-fourth embodiments in which the stored dataindicates a type of said sterile circuit. Variations of thethirty-fourth embodiments may be provided to form additionalthirty-fourth embodiments in which the stored data indicates a date andtime when the sterile circuit was first wetted. Variations of thethirty-fourth embodiments may be provided to form additionalthirty-fourth embodiments that include a treatment device connected tothe common outlet and being of a type that requires a sterilemedicament. Variations of the thirty-fourth embodiments may be providedto form additional thirty-fourth embodiments in which the treatmentdevice includes a blood processing treatment device. Variations of thethirty-fourth embodiments may be provided to form additionalthirty-fourth embodiments in which the treatment device includes anextracorporeal blood treatment device. Variations of the thirty-fourthembodiments may be provided to form additional thirty-fourth embodimentsin which the sterile circuit internal fluid compartment is sterile as aresult of said sterile circuit being a product of manufacture thatincludes sealing a disposable unit and sterilizing it. Variations of thethirty-fourth embodiments may be provided to form additionalthirty-fourth embodiments in which the sterile circuit internal fluidcompartment is sterile as a result of said sterile circuit beingsterilized and used for a limited time to prevent colonization ofbacteria. Variations of the thirty-fourth embodiments may be provided toform additional thirty-fourth embodiments in which the sterile circuitinternal fluid compartment is sterile as a result of said sterilecircuit being a sterile disposable.

The system of any of claims 311 to 324, wherein the sterile circuitinternal fluid compartment is sterile as a result of a sterilizationprocess. Variations of the thirty-fourth embodiments may be provided toform additional thirty-fourth embodiments in which the sterile circuitincludes sensor and pumping portions positioned and oriented to engagewith a predefined medicament preparation module that controls the flowof fluid therethrough.

A fluid conductivity measurement system can be included in an of theembodiments which three or more conductive electrodes positioned along afluid path are used to measure fluid conductivity form two or moreconduction paths for the measurement of conductivity of a same fluid.

According to thirty-fifth embodiments, the disclosed subject matterincludes a conductivity measurement device with a fluid channel withthree or more electrodes positioned to contact a fluid flowing in saidfluid channel. A conductivity measurement circuit is controlled by acontroller, the controller programmed to control switches to pass acurrent between a first pair of the three or more electrodes and measurea first voltage drop across said first pair at a first time and to passa current between a second pair of the three or more electrodes andmeasure a second voltage drop across said second pair at a second time,where the first pair and the second pair include a same one of the threeor more electrodes and the first and second times are sufficientlycontemporaneous as to correspond to an identical fluid flowing throughsaid channel.

Variations of the thirty-fifth embodiments may be provided to formadditional thirty-fifth embodiments in which the first pair ispositioned at opposite ends of a first enlarged section of said flowchannel. Variations of the thirty-fifth embodiments may be provided toform additional thirty-fifth embodiments in which of the second pair ispositioned at an end of a second enlarged section of said flow channelthat is interconnected with the first. Variations of the thirty-fifthembodiments may be provided to form additional thirty-fifth embodimentsin which the controller is adapted to calculate a single fluidconductivity responsively to the first and second voltage drops.

According to thirty-sixth embodiments, the disclosed subject matterincludes a fluid circuit for preparation of a medicament for renalreplacement therapy. A concentrate container containing acid concentrateis connected for flow communication, through a first pumping tubesegment, to a medicament supply line that has been capped andsterile-sealed at an outlet end thereof. A bicarbonate cartridgecontaining dry bicarbonate buffer compound is of a type that admitswater in an cartridge inlet thereby forming a saturated bicarbonatesolution which is received at a cartridge outlet, the cartridge outletbeing connected for flow communication, through a second pumping tubesegment, to the medicament supply line. A water inlet line is connectedfor flow communication, through a third pumping tube segment, to themedicament supply line and connected for flow communication to thebicarbonate cartridge inlet. The first, second, and third pumping tubesegments are supported by a circuit cartridge which orients, aligns, andexposes for access the first, second, and third pumping tube segmentswith respective actuators of a predefined medicament preparation device.The circuit cartridge contains a first concentration sensor stationpositioned in the medicament supply line downstream of a first junctionwhere a first of the first and second pumping tube segments connects tothe medicament supply line. The circuit cartridge contains a secondconcentration sensor station positioned in the medicament supply linedownstream of both the first junction and a second junction where asecond of the first and second pumping tube segments connects to themedicament supply line.

Variations of the thirty-sixth embodiments may be provided to formadditional thirty-sixth embodiments in which the water inlet line iscapped and sterile-sealed and the entire fluid circuit is sterile.Variations of the thirty-sixth embodiments may be provided to formadditional thirty-sixth embodiments in which the circuit cartridgeincludes a fluid accumulator fluidly coupled between the water inletline and the medicament supply line outlet end that includes apressure-regulating urging element that biases a flexible wall of theaccumulator such that transient changes of fluid pressure therein causeexpansion of the volume of the accumulator. Variations of thethirty-sixth embodiments may be provided to form additional thirty-sixthembodiments in which the fluid circuit is packaged with a box such thatthe circuit cartridge can be detached or removed from the box whileleaving the concentrate container and bicarbonate cartridge intacttherein with lengths of connecting lines between the circuit cartridgeand the box, thereby permitting the circuit cartridge to be installed ina position remote form a position where the box is installed. Variationsof the thirty-sixth embodiments may be provided to form additionalthirty-sixth embodiments in which the fluid circuit is packaged within abox such that the circuit cartridge can be removed from the box whileleaving the concentrate container and bicarbonate cartridge intacttherein with lengths of connecting lines between the circuit cartridgeand the box, thereby permitting the circuit cartridge to be installed ina position remote form a position where the box is installed. Variationsof the thirty-sixth embodiments may be provided to form additionalthirty-sixth embodiments in which the fluid circuit is attached to a boxin such a way that the circuit cartridge can be detached from the boxwhile leaving the concentrate container and bicarbonate cartridge intacttherein with lengths of connecting lines between the circuit cartridgeand the box, thereby permitting the circuit cartridge to be installed ina position remote form a position where the box is installed. Variationsof the thirty-sixth embodiments may be provided to form additionalthirty-sixth embodiments in which the box is principally of cardboard.Variations of the thirty-sixth embodiments may be provided to formadditional thirty-sixth embodiments in which each of the concentrationsensor stations includes a liquid conductivity sensor and temperaturesensor portions. Variations of the thirty-sixth embodiments may beprovided to form additional thirty-sixth embodiments in which thetemperature sensor portion includes a flow chamber with a flat surfaceto permit a temperature sensor to be placed against the flat surface ofa predefined sensor of the predefined medicament preparation device.Variations of the thirty-sixth embodiments may be provided to formadditional thirty-sixth embodiments in which each of the concentrationstations includes, connected in series, two independent conductivitysensors and two independent temperature sensor portions. Variations ofthe thirty-sixth embodiments may be provided to form additionalthirty-sixth embodiments in which the medicament supply line includes awaste outlet branch that is in direct fluid communication with theaccumulator, the waste outlet line being capped and sterile-sealed, themedicament supply line outlet line and waste outlet branches havingpinching portions supported in an open section of the circuit cartridgeto permit access by pinching actuators.

According to thirty-seventh embodiments, the disclosed subject matterincludes a fluid circuit for preparation of a medicament for renalreplacement therapy. A first container containing acid concentrate isconnected for flow communication, through a first pumping tube segment,to a medicament supply line that has been capped and sterile-sealed atan outlet end thereof. A second container contains a buffer concentrateconnected for flow communication, through a second pumping tube segment,to the medicament supply line. A water inlet line is connected for flowcommunication, through a third pumping tube segment, to the medicamentsupply line. The first, second, and third pumping tube segments aresupported by a circuit cartridge which orients, aligns, and exposes foraccess the first, second, and third pumping tube segments withrespective actuators of a predefined medicament preparation device. Thecircuit cartridge contains a first concentration sensor stationpositioned in the medicament supply line downstream of a first junctionwhere a first of the first and second pumping tube segments connects tothe medicament supply line. The circuit cartridge contains a secondconcentration sensor station positioned in the medicament supply linedownstream of both the first junction and a second junction where asecond of the first and second pumping tube segments connects to themedicament supply line.

Variations of the thirty-seventh embodiments may be provided to formadditional thirty-seventh embodiments in which the circuit cartridgeincludes a fluid accumulator fluidly coupled between the water inletline and the medicament supply line outlet end that includes apressure-regulating urging element that biases a flexible wall of theaccumulator such that transient changes of fluid pressure therein causeexpansion of the volume of the accumulator. Variations of thethirty-seventh embodiments may be provided to form additionalthirty-seventh embodiments in which the fluid circuit is packaged with abox such that the circuit cartridge can be detached or removed from thebox while leaving the first and second containers therein with lengthsof connecting lines between the circuit cartridge and the box, therebypermitting the circuit cartridge to be installed in a position remoteform a position where the box is installed. Variations of thethirty-seventh embodiments may be provided to form additionalthirty-seventh embodiments in which the fluid circuit is packaged withina box such that the circuit cartridge can be removed from the box whileleaving the first and second containers therein with lengths ofconnecting lines between the circuit cartridge and the box, therebypermitting the circuit cartridge to be installed in a position remoteform a position where the box is installed. Variations of thethirty-seventh embodiments may be provided to form additionalthirty-seventh embodiments in which the fluid circuit is attached to abox in such a way that the circuit cartridge can be detached from thebox while leaving the first and second containers therein with lengthsof connecting lines between the circuit cartridge and the box, therebypermitting the circuit cartridge to be installed in a position remoteform a position where the box is installed. Variations of thethirty-seventh embodiments may be provided to form additionalthirty-seventh embodiments in which the box is principally of cardboard.Variations of the thirty-seventh embodiments may be provided to formadditional thirty-seventh embodiments in which wherein each of theconcentration sensor stations includes a liquid conductivity sensor andtemperature sensor portions. Variations of the thirty-seventhembodiments may be provided to form additional thirty-seventhembodiments in which the temperature sensor portion includes a flowchamber with a flat surface to permit a temperature sensor to be placedagainst the flat surface of a predefined sensor of the predefinedmedicament preparation device. Variations of the thirty-seventhembodiments may be provided to form additional thirty-seventhembodiments in which each of the concentration stations includes,connected in series, two independent conductivity sensors and twoindependent temperature sensor portions. Variations of thethirty-seventh embodiments may be provided to form additionalthirty-seventh embodiments in which the medicament supply line includesa waste outlet branch that is in direct fluid communication with theaccumulator, the waste outlet line being capped and sterile-sealed, themedicament supply line outlet line and waste outlet branches havingpinching portions supported in an open section of the circuit cartridgeto permit access by pinching actuators. Variations of the thirty-seventhembodiments may be provided to form additional thirty-seventhembodiments in which the water inlet line is capped and sterile-sealedand the entire fluid circuit is sterile.

According to thirty-eighth embodiments, the disclosed embodimentsinclude a medicament preparation system. A medicament generation systemhas actuators and sensors positioned and shaped to interface a fluidcircuit. The fluid includes

a first container containing acid concentrate connected for flowcommunication, through a first pumping tube segment, to a medicamentsupply line that has been capped and sterile-sealed at an outlet endthereof;

a second container containing a buffer concentrate connected for flowcommunication, through a second pumping tube segment, to the medicamentsupply line; and

a water inlet line of the medicament supply line, connected for flowcommunication, through a third pumping tube segment, to the medicamentsupply line.

The fluid circuit is a disposable replaceable component and that forms asterile unit that is sealed against ingress of contaminants from theexternal environment. A water purification plant is connectable to theinlet, the water purification plant has an outlet that is connectable tothe inlet to receive purified water from through the water inlet line. Acontroller has a processor configured to calculate a permissible lifefor utilization thereof responsively to at least one of a volume offluid passing through the medicament supply line, a volume of waterpassing through the water inlet, and a length of time since water firstflowed through the water inlet.

Variations of the thirty-eighth embodiments may be provided to formadditional thirty-eighth embodiments that include a sterile filter inthe water inlet line positioned to filter all water entering themedicament supply line. Variations of the thirty-eighth embodiments maybe provided to form additional thirty-eighth embodiments in which thefluid circuit is a disposable replaceable component that is sterile.Variations of the thirty-eighth embodiments may be provided to formadditional thirty-eighth embodiments in which the water purificationplant is connectable to the inlet through a sterile filter positioned inan outlet thereof, the sterile filter having a pore size that ensuressterility of the water entering the water inlet line. Variations of thethirty-eighth embodiments may be provided to form additionalthirty-eighth embodiments in which the water purification plant isconnectable to the inlet through a sterile filter positioned in anoutlet thereof, the sterile filter having a pore size that ensuressterility of the water entering the water inlet line. Variations of thethirty-eighth embodiments may be provided to form additionalthirty-eighth embodiments in which the water purification plant isconnectable to the inlet through a sterile filter positioned in anoutlet thereof, the sterile filter having a pore size that ensuressterility of the water entering the water inlet line. Variations of thethirty-eighth embodiments may be provided to form additionalthirty-eighth embodiments in which the first, second, and third pumpingtube segments are supported by a circuit cartridge which orients,aligns, and exposes for access the first, second, and third pumping tubesegments with respective actuators of a predefined medicamentpreparation device. Variations of the thirty-eighth embodiments may beprovided to form additional thirty-eighth embodiments in which thecircuit cartridge contains a first concentration sensor stationpositioned in the medicament supply line downstream of a first junctionwhere a first of the first and second pumping tube segments connects tothe medicament supply line. Variations of the thirty-eighth embodimentsmay be provided to form additional thirty-eighth embodiments in whichthe circuit cartridge contains a second concentration sensor stationpositioned in the medicament supply line downstream of both the firstjunction and a second junction where a second of the first and secondpumping tube segments connects to the medicament supply line. Variationsof the thirty-eighth embodiments may be provided to form additionalthirty-eighth embodiments in which the circuit cartridge containsredundant sensor stations positioned in the medicament supply linedownstream of both the first junction and a second junction. Variationsof the thirty-eighth embodiments may be provided to form additionalthirty-eighth embodiments in which the circuit cartridge includes afluid accumulator fluidly coupled between the water inlet line and themedicament supply line outlet end that includes a pressure-regulatingurging element that biases a flexible wall of the accumulator such thattransient changes of fluid pressure therein cause expansion of thevolume of the accumulator. Variations of the thirty-eighth embodimentsmay be provided to form additional thirty-eighth embodiments in whichthe fluid circuit is packaged with a box such that the circuit cartridgecan be detached or removed from the box while leaving the first andsecond containers therein with lengths of connecting lines between thecircuit cartridge and the box, thereby permitting the circuit cartridgeto be installed in a position remote form a position where the box isinstalled. Variations of the thirty-eighth embodiments may be providedto form additional thirty-eighth embodiments in which the fluid circuitis packaged within a box such that the circuit cartridge can be removedfrom the box while leaving the first and second containers therein withlengths of connecting lines between the circuit cartridge and the box,thereby permitting the circuit cartridge to be installed in a positionremote form a position where the box is installed. Variations of thethirty-eighth embodiments may be provided to form additionalthirty-eighth embodiments in which the fluid circuit is attached to abox in such a way that the circuit cartridge can be detached from thebox while leaving the first and second containers therein with lengthsof connecting lines between the circuit cartridge and the box, therebypermitting the circuit cartridge to be installed in a position remoteform a position where the box is installed. Variations of thethirty-eighth embodiments may be provided to form additionalthirty-eighth embodiments in which the box is principally of cardboard.Variations of the thirty-eighth embodiments may be provided to formadditional thirty-eighth embodiments in which each of the concentrationsensor stations includes a liquid conductivity sensor and temperaturesensor portions. Variations of the thirty-eighth embodiments may beprovided to form additional thirty-eighth embodiments in which thetemperature sensor portion includes a flow chamber with a flat surfaceto permit a temperature sensor to be placed against the flat surface ofa predefined sensor of the predefined medicament preparation device.Variations of the thirty-eighth embodiments may be provided to formadditional thirty-eighth embodiments in which each of the concentrationstations includes, connected in series, two independent conductivitysensors and two independent temperature sensor portions. Variations ofthe thirty-eighth embodiments may be provided to form additionalthirty-eighth embodiments in which the medicament supply line includes awaste outlet branch that is in direct fluid communication with theaccumulator, the waste outlet line being capped and sterile-sealed, themedicament supply line outlet line and waste outlet branches havingpinching portions supported in an open section of the circuit cartridgeto permit access by pinching actuators.

According to thirty-ninth embodiments, the disclosed subject matterincludes system for providing medicament. A circuit component withmultiple fluid circuits is interconnected to permit two or morecomponent fluids to be combined to form a product medicament, themultiple fluid circuits having respective inlets for each of the two ormore component fluids and a common outlet, the common outlet beingfluidly connected by the circuit component to the respective inlets toprovide a combined medicament product. The circuit component defines asealed internal volume such that internal fluid compartment defined bythe multiple fluid circuits is isolated from an external environment,including the respective inlets.

Variations of the thirty-ninth embodiments may be provided to formadditional thirty-ninth embodiments in which the circuit componentincludes one or more concentration measurement stations including fluidconductivity and temperature measurement portions which are positionedwithin the fluid circuit to detect conductivity and temperature ofmixtures of the two or more component fluids and further positioned,when the circuit component is loaded in a predefined medicamentpreparation apparatus, to engage with sensor components to generateconductivity and temperature signals of the mixtures. Variations of thethirty-ninth embodiments may be provided to form additional thirty-ninthembodiments in which the internal volume is sterile. Variations of thethirty-ninth embodiments may be provided to form additional thirty-ninthembodiments in which the circuit component multiple fluid circuitsdefine a sterile barrier that includes a sterilizing filter positionedat at least one of the respective inlets and having a pore sizesufficiently small to filter and sterilize a respective one of thecomponent fluids that may flow therethrough. Variations of thethirty-ninth embodiments may be provided to form additional thirty-ninthembodiments in which the multiple fluid circuits include a respectiveVariations of the thirty-ninth embodiments may be provided to formadditional thirty-ninth embodiments that include a water purificationplant connected to the circuit component to deliver water, the waterbeing one of the two or more component fluids, the water purificationplant being connected through one of the respective inlets, the one ofthe respective inlets having a sterilizing filter with a pore sizesufficiently small to filter and sterilize water flowing into thecircuit component through the one of the respective inlets. Variationsof the thirty-ninth embodiments may be provided to form additionalthirty-ninth embodiments that include a controller the controller beingadapted to receive prior use data indicating a period of time since themultiple fluid circuits interior volumes were first wetted and to outputa command signal indicating whether the circuit component is safe touse. Variations of the thirty-ninth embodiments may be provided to formadditional thirty-ninth embodiments that include a data reader,connected to the controller, that sends status data to the controller,the status data being derived at least in part on data from stored dataread by the data reader from a data store attached to the circuitcomponent. Variations of the thirty-ninth embodiments may be provided toform additional thirty-ninth embodiments in which the stored dataindicates a type of the circuit component. Variations of thethirty-ninth embodiments may be provided to form additional thirty-ninthembodiments in which the stored data indicates a date and time when thesterile circuit was first wetted. Variations of the thirty-ninthembodiments may be provided to form additional thirty-ninth embodimentsthat include a treatment device connected to the common outlet and beingof a type that requires a sterile medicament. Variations of thethirty-ninth embodiments may be provided to form additional thirty-ninthembodiments in which the treatment device includes a blood processingtreatment device. Variations of the thirty-ninth embodiments may beprovided to form additional thirty-ninth embodiments in which thetreatment device includes an extracorporeal blood treatment device.Variations of the thirty-ninth embodiments may be provided to formadditional thirty-ninth embodiments in which the circuit componentinternal fluid compartment is sterile as a result of the circuitcomponent being a product of manufacture that includes sealing adisposable unit and sterilizing it. Variations of the thirty-ninthembodiments may be provided to form additional thirty-ninth embodimentsin which the circuit component internal fluid compartment is sterile asa result of the circuit component being sterilized and used for alimited time to prevent colonization of bacteria. Variations of thethirty-ninth embodiments may be provided to form additional thirty-ninthembodiments in which the circuit component internal fluid compartment issterile as a result of the circuit component being a sterile disposable.Variations of the thirty-ninth embodiments may be provided to formadditional thirty-ninth embodiments in which the circuit componentinternal fluid compartment is sterile as a result of a sterilizationprocess. Variations of the thirty-ninth embodiments may be provided toform additional thirty-ninth embodiments in which the circuit componentincludes sensor and pumping portions positioned and oriented to engagewith a predefined medicament preparation module that controls the flowof fluid therethrough.

According to fortieth embodiments, the disclosed subject matter includesa fluid circuit for a predefined medicament preparation system havingactuators and sensors that are interoperable with the fluid circuit, thefluid circuit. A circuit component with multiple fluid circuits isinterconnected to permit two or more component fluids to be combined toform a product medicament, the multiple fluid circuits having respectiveinlets for each of the two or more component fluids and a common outlet,the common outlet being fluidly connected by the circuit component tothe respective inlets to provide a combined medicament product Thecircuit component defines a sealed internal fluid compartment defined bythe multiple fluid circuits is isolated from an external environment,including the respective inlets. One or more concentration measurementstations include fluid conductivity and temperature measurement portionswhich are positioned within the fluid circuit to detect conductivity andtemperature of mixtures of the two or more component fluids and furtherpositioned, when the circuit component is loaded in the predefinedmedicament preparation system, to engage with sensor components thereofto generate conductivity and temperature signals of the mixtures.

Variations of the fortieth embodiments may be provided to formadditional fortieth embodiments in which the sealed internal fluidcompartment is sealed against ingress of contaminants by a sterilizingfilter positioned at at least one of the respective inlets and having apore size sufficiently small to filter and sterilize a respective one ofthe component fluids that may flow therethrough. Variations of thefortieth embodiments may be provided to form additional fortiethembodiments in which the multiple fluid circuits include a respectivepumping tube segment for each of the component fluids, each being joinedto the common outlet. Variations of the fortieth embodiments may beprovided to form additional fortieth embodiments in which one of therespective inlets includes a water inlet connectable to a waterpurification plant to deliver water as one of the two or more componentfluids, the one of the respective inlets having a sterilizing filterwith a pore size sufficiently small to filter and sterilize waterflowing into the circuit component through the one of the respectiveinlets. Variations of the fortieth embodiments may be provided to formadditional fortieth embodiments in which a data reader, attached to thecircuit component, storing data indicating data indicating at least onecharacteristic of a usage history of the circuit component. Variationsof the fortieth embodiments may be provided to form additional fortiethembodiments that include a data reader, attached to the circuitcomponent, storing data indicating data indicating a type of the circuitcomponent. Variations of the fortieth embodiments may be provided toform additional fortieth embodiments that include a data reader,attached to the circuit component, storing data indicating a first timethe circuit component was first wetted. Variations of the fortiethembodiments may be provided to form additional fortieth embodiments inwhich the circuit component internal fluid compartment is sterile as aresult of the circuit component being a sterile disposable.

According to forty-first embodiments, the disclosed subject matterincludes a system for providing medicament. A circuit component hasmultiple fluid circuits interconnected to permit two or more componentfluids to be combined to form a product medicament, the multiple fluidcircuits having respective inlets for each of the two or more componentfluids and a common outlet, the common outlet being fluidly connected bythe circuit component to the respective inlets to provide a combinedmedicament product. The circuit component defines a sealed internalfluid compartment defined by the multiple fluid circuits is isolatedfrom an external environment, including the respective inlets. Thecircuit component includes one or more concentration measurementstations including fluid conductivity and temperature measurementportions. A controller with sensor components generates conductivity andtemperature signals, the sensor components engaging with conductivityand temperature measurement portions of the circuit component that arepositioned to detect temperature and conductivity of mixtures of the twoor more components.

Variations of the forty-first embodiments may be provided to formadditional forty-first embodiments in which the sealed internal fluidcompartment has a sterile barrier that includes a sterilizing filterpositioned at at least one of the respective inlets and having a poresize sufficiently small to filter and sterilize a respective one of thecomponent fluids that may flow therethrough. Variations of theforty-first embodiments may be provided to form additional forty-firstembodiments in which the multiple fluid circuits include a respectivepumping tube segment for each of the component fluids, each being joinedto the common outlet. Variations of the forty-first embodiments may beprovided to form additional forty-first embodiments that include a waterpurification plant connected to the circuit component to deliver water,the water being one of the two or more component fluids, the waterpurification plant being connected through one of the respective inlets,the one of the respective inlets having a sterilizing filter with a poresize sufficiently small to filter and sterilize water flowing into thecircuit component through the one of the respective inlets. Variationsof the forty-first embodiments may be provided to form additionalforty-first embodiments that include a controller the controller beingadapted to receive prior use data indicating a period of time since themultiple fluid circuits interior volumes were first wetted and to outputa command signal indicating whether the circuit component is safe touse. Variations of the forty-first embodiments may be provided to formadditional forty-first embodiments that include a data reader, connectedto the controller, that sends status data to the controller, the statusdata being derived at least in part on data from stored data read by thedata reader from a data store attached to the circuit component.Variations of the forty-first embodiments may be provided to formadditional forty-first embodiments in which the stored data indicates atype of the circuit component. Variations of the forty-first embodimentsmay be provided to form additional forty-first embodiments in which thestored data indicates a date and time when the circuit component wasfirst wetted. Variations of the forty-first embodiments may be providedto form additional forty-first embodiments that include a treatmentdevice connected to the common outlet and being of a type that requiresa sterile medicament. Variations of the forty-first embodiments may beprovided to form additional forty-first embodiments in which thetreatment device includes a blood processing treatment device.Variations of the forty-first embodiments may be provided to formadditional forty-first embodiments in which the treatment deviceincludes an extracorporeal blood treatment device. Variations of theforty-first embodiments may be provided to form additional forty-firstembodiments in which the circuit component internal fluid compartment issterile as a result of the circuit component being a product ofmanufacture that includes sealing a disposable unit and sterilizing it.

According to forty-second embodiments, the disclosed subject matterincludes a method of performing an extracorporeal blood treatment. Themethod includes, at a first time, flowing sterile component fluids toform a medicament into a sterile compartment, the flowing includingwetting the sterile compartment. The method includes mixing the sterilecomponent fluids to form a medicament and supplying the same, at thefirst time, to a medical treatment apparatus for providing a medicaltreatment. The method includes at a second time, with a controller andresponsively to use-permission data, permitting or preventing a furtherflowing the sterile component fluids to form a medicament into thesterile compartment. The method includes at the second time, uponinitially preventing the further flowing, permitting a further flowingsterile component fluids to form a medicament into the same or a newsterile compartment after a replacement or sterilization of the sterilecompartment so as to ensure sterility thereof, the permitting includingverifying that the sterile compartment has been replaced or sterilized.The use-permission data is indicative of a time since the sterilecompartment was first wetted for preparing medicament, a volume of fluidprocessed by the sterile compartment, a date of manufacture of thesterile compartment, a lot number of the sterile compartment, or a typeof the sterile compartment.

Variations of the forty-second embodiments may be provided to formadditional forty-second embodiments in which measuring a conductivityand temperature of a mixture resulting from the mixing.

According to forty-third embodiments, the disclosed subject matterincludes a method of performing an extracorporeal blood treatment. Themethod includes, at a first time, flowing component fluids to form amedicament into a sterile compartment, the flowing including wetting thesterile compartment and sterilizing the component fluids to ensure thecomponent fluids and sterile compartment are sterile after the firsttime. The method includes, mixing the component fluids to form amedicament and supplying the same, at the first time, to a medicaltreatment apparatus for providing a medical treatment. The methodincludes, at a second time, with a controller and responsively touse-permission data, permitting or preventing a further flowingcomponent fluids to form a medicament into the sterile compartment, thesecond flowing including sterilizing the component fluids. The methodincludes, at the second time, upon initially preventing the furtherflowing, permitting a further flowing component fluids to form amedicament into the same or a new sterile compartment after areplacement or sterilization of the sterile compartment so as to ensuresterility thereof, the permitting including verifying that the sterilecompartment has been replaced or sterilized. The use-permission data isindicative of a time since the sterile compartment was first wetted forpreparing medicament, a volume of fluid processed by the sterilecompartment, a date of manufacture of the sterile compartment, a lotnumber of the sterile compartment, or a type of the sterile compartment.The forty-third embodiment may be modified to include measuring aconductivity and temperature of a mixture resulting from the mixing.

According to forty-fourth embodiments, the disclosed subject matterincludes a method of providing sterile dialysate for a treatment. Themethod includes pumping sterile water and sterile concentrates into amixing component. The method includes using the mixing component, mixingthe sterile water and sterile medicaments so as to generate a sterilemedicament. The method includes flowing the sterile medicament to ablood treatment system.

Variations of the forty-fourth embodiments may be provided to formadditional forty-fourth embodiments in which the pumping sterile waterincludes purifying tap water and sterile-filtering a product of thepurifying. Variations of the forty-fourth embodiments may be provided toform additional forty-fourth embodiments in which the pumping sterileconcentrates includes providing a sealed sterile container pre-filledwith concentrate and sterilized. Variations of the forty-fourthembodiments may be provided to form additional forty-fourth embodimentsin which the pumping sterile concentrates includes providing a sealedsterile container pre-filled with sterile concentrate and sterilizingthe container. Variations of the forty-fourth embodiments may beprovided to form additional forty-fourth embodiments that includeflowing the sterile medicament at a first time for a first treatment,stopping the pumping and mixing, setting up for a second treatment at asecond time while permitting the mixing component to remain wetted inthe rest interval between the first and second times, and repeating thepumping and mixing to perform a second treatment at the second time.Variations of the forty-fourth embodiments may be provided to formadditional forty-fourth embodiments that include flowing the sterilemedicament at a first time for a first treatment, stopping the pumpingand mixing, setting up for a second treatment at a second time whilepermitting the mixing component to remain wetted in the interval betweenthe first and second times, using a controller, determining whether apredetermined time interval has elapsed since the first time andrepeating the pumping and mixing to perform a second treatment at thesecond time only if the rest interval does not exceed the predeterminedtime interval.

It will be appreciated that the modules, processes, systems, andsections described above can be implemented in hardware, hardwareprogrammed by software, software instruction stored on a non-transitorycomputer readable medium or a combination of the above. For example, amethod for controlling the generating of a medicament or treatment fluid(or methods therewithin such as for the generating of purified water)can be implemented, for example, using a processor configured to executea sequence of programmed instructions stored on a non-transitorycomputer readable medium. For example, the processor can include, butnot be limited to, a personal computer or workstation or other suchcomputing system that includes a processor, microprocessor,microcontroller device, or is comprised of control logic includingintegrated circuits such as, for example, an Application SpecificIntegrated Circuit (ASIC). The instructions can be compiled from sourcecode instructions provided in accordance with a programming languagesuch as Java, C++, C#.net or the like. The instructions can alsocomprise code and data objects provided in accordance with, for example,the Visual Basic™ language, LabVIEW, or another structured orobject-oriented programming language. The sequence of programmedinstructions and data associated therewith can be stored in anon-transitory computer-readable medium such as a computer memory orstorage device which may be any suitable memory apparatus, such as, butnot limited to read-only memory (ROM), programmable read-only memory(PROM), electrically erasable programmable read-only memory (EEPROM),random-access memory (RAM), flash memory, disk drive and the like.

Furthermore, the modules, processes, systems, and sections can beimplemented as a single processor or as a distributed processor.Further, it should be appreciated that the steps mentioned above may beperformed on a single or distributed processor (single and/ormulti-core). Also, the processes, modules, and sub-modules described inthe various figures of and for embodiments above may be distributedacross multiple computers or systems or may be co-located in a singleprocessor or system. Exemplary structural embodiment alternativessuitable for implementing the modules, sections, systems, means, orprocesses described herein are provided below.

The modules, processors or systems described above can be implemented asa programmed general purpose computer, an electronic device programmedwith microcode, a hard-wired analog logic circuit, software stored on acomputer-readable medium or signal, an optical computing device, anetworked system of electronic and/or optical devices, a special purposecomputing device, an integrated circuit device, a semiconductor chip,and a software module or object stored on a computer-readable medium orsignal, for example.

Embodiments of the method and system (or their sub-components ormodules), may be implemented on a general-purpose computer, aspecial-purpose computer, a programmed microprocessor or microcontrollerand peripheral integrated circuit element, an ASIC or other integratedcircuit, a digital signal processor, a hardwired electronic or logiccircuit such as a discrete element circuit, a programmed logic circuitsuch as a programmable logic device (PLD), programmable logic array(PLA), field-programmable gate array (FPGA), programmable array logic(PAL) device, or the like. In general, any process capable ofimplementing the functions or steps described herein can be used toimplement embodiments of the method, system, or a computer programproduct (software program stored on a non-transitory computer readablemedium).

Furthermore, embodiments of the disclosed method, system, and computerprogram product may be readily implemented, fully or partially, insoftware using, for example, object or object-oriented softwaredevelopment environments that provide portable source code that can beused on a variety of computer platforms. Alternatively, embodiments ofthe disclosed method, system, and computer program product can beimplemented partially or fully in hardware using, for example, standardlogic circuits or a very-large-scale integration (VLSI) design. Otherhardware or software can be used to implement embodiments depending onthe speed and/or efficiency requirements of the systems, the particularfunction, and/or particular software or hardware system, microprocessor,or microcomputer being utilized. Embodiments of the method, system, andcomputer program product can be implemented in hardware and/or softwareusing any known or later developed systems or structures, devices and/orsoftware by those of ordinary skill in the applicable art from thefunction description provided herein and with a general basic knowledgeof control systems, sensors, electromechanical effecters and/or computerprogramming arts.

Moreover, embodiments of the disclosed method, system, and computerprogram product can be implemented in software executed on a programmedgeneral purpose computer, a special purpose computer, a microprocessor,or the like.

It is, thus, apparent that there is provided, in accordance with thepresent disclosure, medicament preparation and treatment devices,methods, and systems. Many alternatives, modifications, and variationsare enabled by the present disclosure. Features of the disclosedembodiments can be combined, rearranged, omitted, etc., within the scopeof the invention to produce additional embodiments. Furthermore, certainfeatures may sometimes be used to advantage without a corresponding useof other features. Accordingly, Applicant intends to embrace all suchalternatives, modifications, equivalents, and variations that are withinthe spirit and scope of the present invention.

The invention claimed is:
 1. A fluid circuit for preparation of amedicament for renal replacement therapy, comprising: a concentratecontainer containing acid concentrate connected for flow communication,through a first pumping tube segment, to a medicament supply line thathas been capped and sterile-sealed at an outlet end thereof; abicarbonate cartridge containing dry bicarbonate buffer compound, thebicarbonate cartridge being of a type that admits water in a cartridgeinlet thereby forming a saturated bicarbonate solution which is receivedat a cartridge outlet, the cartridge outlet being connected for flowcommunication, through a second pumping tube segment, to the medicamentsupply line; and a water inlet line, capped and sterile-sealed,connected for flow communication, through a third pumping tube segment,to the medicament supply line and connected for flow communication tothe bicarbonate cartridge inlet; the first, second, and third pumpingtube segments being supported by a circuit cartridge which orients,aligns, and exposes for access the first, second, and third pumping tubesegments with respective actuators of a predefined medicamentpreparation device; the circuit cartridge containing a firstconcentration sensor station positioned in said medicament supply linedownstream of a first junction where the first pumping tube segmentconnects to the medicament supply line; the circuit cartridge containinga second concentration sensor station positioned in said medicamentsupply line downstream of both said first junction and a second junctionwhere the second pumping tube segment connects to the medicament supplyline, wherein each of said concentration sensor stations includes aliquid conductivity sensor and a temperature sensor portion, thetemperature sensor portion includes a flow chamber with a flat surfaceto permit a temperature sensor to be placed against said flat surface ofa predefined sensor of the predefined medicament preparation device, andthe entire fluid circuit is sterile.
 2. The circuit of claim 1, whereinthe circuit cartridge includes a fluid accumulator fluidly coupledbetween the water inlet line and the medicament supply line outlet endthat includes a pressure-regulating urging element that biases aflexible wall of the accumulator such that transient changes of fluidpressure therein cause expansion of the volume of the accumulator. 3.The circuit of claim 1, wherein the fluid circuit is packaged with a boxsuch that the circuit cartridge can be detached or removed from the boxwhile leaving the concentrate container and bicarbonate cartridge intacttherein with lengths of connecting lines between the circuit cartridgeand the box, thereby permitting the circuit cartridge to be installed ina position remote form a position where the box is installed.
 4. Thecircuit of claim 1, wherein the fluid circuit is packaged within a boxsuch that the circuit cartridge can be removed from the box whileleaving the concentrate container and bicarbonate cartridge intacttherein with lengths of connecting lines between the circuit cartridgeand the box, thereby permitting the circuit cartridge to be installed ina position remote form a position where the box is installed.
 5. Thecircuit of claim 1, wherein the fluid circuit is attached to a box insuch a way that the circuit cartridge can be detached from the box whileleaving the concentrate container and bicarbonate cartridge intacttherein with lengths of connecting lines between the circuit cartridgeand the box, thereby permitting the circuit cartridge to be installed ina position remote form a position where the box is installed.
 6. Thecircuit of claim 3, wherein the box is principally of cardboard.
 7. Thecircuit of claim 1, wherein each of said concentration stationsincludes, connected in series, two independent conductivity sensors andtwo independent temperature sensor portions.
 8. The circuit of claim 2,wherein the medicament supply line includes a waste outlet branch thatis in direct fluid communication with the accumulator, the waste outletbranch being capped and sterile-sealed, the medicament supply lineoutlet line and waste outlet branch having pinching portions supportedin an open section of said circuit cartridge to permit access bypinching actuators.
 9. A fluid circuit for preparation of a medicamentfor renal replacement therapy, comprising: a first container containingacid concentrate connected for flow communication, through a firstpumping tube segment, to a medicament supply line that has been cappedand sterile-sealed at an outlet end thereof; a second containercontaining a buffer concentrate connected for flow communication,through a second pumping tube segment, to the medicament supply line;and a water inlet line, capped and sterile-sealed, connected for flowcommunication, through a third pumping tube segment, to the medicamentsupply line; the first, second, and third pumping tube segments beingsupported by a circuit cartridge which orients, aligns, and exposes foraccess the first, second, and third pumping tube segments withrespective actuators of a predefined medicament preparation device; thecircuit cartridge containing a first concentration sensor stationpositioned in said medicament supply line downstream of a first junctionwhere the first pumping tube segment connects to the medicament supplyline; the circuit cartridge containing a second concentration sensorstation positioned in said medicament supply line downstream of bothsaid first junction and a second junction where the second pumping tubesegment connects to the medicament supply line, wherein each of saidconcentration sensor stations includes a liquid conductivity sensor anda temperature sensor portion, the temperature sensor portion includes aflow chamber with a flat surface to permit a temperature sensor to beplaced against said flat surface of a predefined sensor of thepredefined medicament preparation device, and the entire fluid circuitis sterile.
 10. The circuit of claim 9, wherein the circuit cartridgeincludes a fluid accumulator fluidly coupled between the water inletline and the medicament supply line outlet end that includes apressure-regulating urging element that biases a flexible wall of theaccumulator such that transient changes of fluid pressure therein causeexpansion of the volume of the accumulator.
 11. The circuit of claim 9,wherein the fluid circuit is packaged with a box such that the circuitcartridge can be detached or removed from the box while leaving thefirst and second containers therein with lengths of connecting linesbetween the circuit cartridge and the box, thereby permitting thecircuit cartridge to be installed in a position remote form a positionwhere the box is installed.
 12. The circuit of claim 9, wherein thefluid circuit is packaged within a box such that the circuit cartridgecan be removed from the box while leaving the first and secondcontainers therein with lengths of connecting lines between the circuitcartridge and the box, thereby permitting the circuit cartridge to beinstalled in a position remote form a position where the box isinstalled.
 13. The circuit of claim 9, wherein the fluid circuit isattached to a box in such a way that the circuit cartridge can bedetached from the box while leaving the first and second containerstherein with lengths of connecting lines between the circuit cartridgeand the box, thereby permitting the circuit cartridge to be installed ina position remote form a position where the box is installed.
 14. Thecircuit of claim 11, wherein the box is principally of cardboard. 15.The circuit of claim 9, wherein each of said concentration stationsincludes, connected in series, two independent conductivity sensors andtwo independent temperature sensor portions.
 16. The circuit of claim10, wherein the medicament supply line includes a waste outlet branchthat is in direct fluid communication with the accumulator, the wasteoutlet branch being capped and sterile-sealed, the medicament supplyline outlet line and waste outlet branch having pinching portionssupported in an open section of said circuit cartridge to permit accessby pinching actuators.